Insulin management

ABSTRACT

A method of managing insulin includes receiving blood glucose measurements on a computing device from a glucometer. The blood glucose measurements are separated by a time interval. The method includes determining, using the computing device, an insulin dose rate based on the blood glucose measurements and determining a blood glucose drop rate based on the blood glucose measurements and the time interval. The method also includes determining a blood glucose percentage drop based on the blood glucose measurements. The method includes decreasing the time interval between blood glucose measurements by the glucometer when the blood glucose drop rate is greater than a threshold drop rate, and decreasing the time interval between blood glucose measurements by the glucometer when the blood glucose percentage drop is greater than a threshold percentage drop.

CROSS REFERENCE TO RELATED APPLICATIONS

This U.S. patent application is a divisional of, and claims priorityunder 35 U.S.C. §121 from, U.S. patent application Ser. No. 14/511,060,filed on Oct. 9, 2014, which claims priority under 35 U.S.C. §119(e) toU.S. Provisional Application 61/934,300, filed on Jan. 31, 2014. Thedisclosures of these prior applications are considered part of thedisclosure of this application and are hereby incorporated by referencein their entireties.

TECHNICAL FIELD

This disclosure relates to a system for managing insulin administrationor insulin dosing.

BACKGROUND

Today, nearly 40% of patients admitted to acute care hospitals in theUnited States experience either hyperglycemia or hypoglycemia, bothserious medical conditions. Many of these patients have diabetes whileothers have fluctuating blood sugars due to trauma, drug reactions,stress and other factors. Nurses and doctors managing these patientsmanually calculate insulin doses using complex paper protocols.

Manual calculation may not be accurate due to human error, which canlead to patient safety issues. Different institutions use multiple andsometimes conflicting protocols to manually calculate an insulin dosage.Moreover, the protocols may include extra paperwork that nurses andphysicians have to manage, which in turn leads to workflowinefficiencies, additional operating costs, and employee satisfactionissues. SCIP (Surgical Care Improvement Project) scores, length of stay,readmission and even mortality rates adversely affect sub-optimalglycemic management.

The prevalent method of regulating continuous intravenous insulininfusion is by using a set of written instructions, known as a paperprotocol. Paper protocols often involve a tree of conditional statementsand some use of tables of numbers, for which a given blood glucose valuedictates the use of a different column of insulin rates. The complexityof these paper protocols multiplies the probability of error by thenurses using them. These errors can lead to hypoglycemic events.

SUMMARY

One aspect of the disclosure provides a method of managing insulin. Themethod includes receiving blood glucose measurements on a computingdevice from a glucometer. The blood glucose measurements are separatedby a time interval. For each time interval, the method includesdetermining, using the computing device, an intravenous insulin infusionrate based on the blood glucose measurements of the time interval. Themethod further includes determining, using the computing device, a bloodglucose percentage drop based on the blood glucose measurements (e.g.,between a current blood glucose measurement and a previous blood glucosemeasurement). The method further includes determining, using thecomputing device, a blood glucose drop rate based on the blood glucosemeasurements and the time interval. The method also includes decreasingthe time interval between blood glucose measurements by the glucometerwhen the blood glucose percentage drop is greater than a thresholdpercentage drop and decreasing the time interval between blood glucosemeasurements by the glucometer when the blood glucose drop rate isgreater than a threshold drop rate. The method further includes sendingthe intravenous insulin infusion rate from the computing device to aninsulin administration device.

Implementations of the disclosure may include one or more of thefollowing optional features. In some implementations, the methodincludes setting the time interval between the blood glucosemeasurements by the glucometer to a default time interval or a minimumof a preconfigured hypoglycemia time interval when a current bloodglucose measurement is less than a threshold hypoglycemia blood glucosevalue. The method includes setting the time interval to a minimum of apreconfigured short time interval when the current blood glucosemeasurement is greater than the threshold hypoglycemia blood glucosevalue and less than a lower limit of a blood glucose target range andthe blood glucose percentage drop is greater than a low blood glucosepercentage drop limit or the current blood glucose measurement isgreater than or equal to the lower limit of the blood glucose targetrange and the blood glucose percentage drop is greater than a regularblood glucose percentage drop limit. In some examples, the methodincludes setting the time interval to a minimum of a preconfigured bloodglucose drop rate time interval when the blood glucose drop rate isgreater than a blood glucose drop rate limit, a preconfigured long timeinterval when the blood glucose measurements have been within the bloodglucose target range for a duration of time greater than a stable timeperiod or a preconfigured meal bolus time interval when a meal bolusprogram is in operation. The preconfigured hypoglycemia time interval isless than the short time interval, the short time interval is less thanthe blood glucose drop rate time interval, the blood glucose drop ratetime interval is less than the long time interval, and the meal bolustime interval is less than the long time interval.

In some examples, the method includes leaving the multiplier unchangedbetween time intervals when the current blood glucose measurement isgreater than an upper limit of a blood glucose target range and a ratioof the current blood glucose measurement divided by a previous bloodglucose measurement is less than or equal to a threshold ratio. Themethod further includes multiplying the multiplier by a change factorwhen the current blood glucose measurement divided by the previous bloodglucose measurement is greater than the threshold ratio. Additionally oralternatively, the method may include the constant being equal to 60mg/dl and the threshold ratio being equal to 0.85. The method mayfurther include dividing the multiplier by the change factor when thecurrent blood glucose measurement is less than a lower limit of theblood glucose target range.

The method may further include, in response to receiving an indicationof patient solid food consumption, increasing the intravenous insulininfusion rate and maintaining the multiplier unchanged for at least twotime intervals. In some examples, the method includes receiving, at thecomputing device, a number of estimated grams of carbohydrates for ameal and determining, using the computing device, an estimated mealbolus in units of insulin based on the number of estimated grams ofcarbohydrates and a carbohydrate-insulin-ratio. The method may furtherinclude determining, using the computing device, an estimated meal bolusinsulin rate, based on the estimated meal bolus, an available deliverytime, and a configurable constant, and determining, using the computingdevice, a total insulin rate as a sum of the intravenous insulin rateand the estimated meal bolus insulin rate. The method may furtherinclude sending the total insulin rate from the computing device to theinsulin administration device. Additionally or alternatively, the methodmay include dividing a total meal time into meal time sub-intervals, afirst meal time sub-interval starting with a pre-meal blood glucosemeasurement before receiving the indication of patient solid foodconsumption, and determining, using the computing device, the totalinsulin rate for each meal time sub-interval in succession.

In some examples, the method includes receiving, at the computingdevice, a number of actual grams of carbohydrates for the meal during asubsequent time interval after the first time interval and determining,using the computing device, an actual meal bolus based on the number ofactual grams of carbohydrates. The method also includes, determining anestimated delivered meal bolus by multiplying the estimated meal bolusrate times an elapsed delivery time. The method may further includedetermining a remaining meal bolus in units of insulin, using thecomputing device, by subtracting a product of the estimated deliveredmeal bolus insulin rate and an actual delivery time from the actual mealbolus. In addition, the method may include determining, using thecomputing device, a revised meal bolus insulin rate as the remainingmeal bolus divided by a time remaining in the total meal time anddetermining, using the computing device, a revised total insulin rate asa sum of the intravenous insulin rate and the revised meal bolus insulinrate. Further, the method may include sending the revised total insulinrate from the computing device to the insulin administration device. Themethod may also include decreasing the time interval to less than thedefault time interval for the one or more meal time sub-intervals.

In some implementations, the method includes electronically displayingon a display in communication with the computing device a warning andblocking transition to a subcutaneous administration of insulin when thecurrent blood glucose measurement is outside a stability target rangeand electronically displaying on the display a warning when the currentblood glucose measurement is within the stability target range for lessthan a threshold stability period of time. The method may furtherinclude determining, using the computing device, a total daily dose ofinsulin based on the multiplier when the current blood glucosemeasurement is within a stability target range for a threshold period oftime. The method further includes determining, using the computingdevice, recommended insulin dose comprising a daily basal insulin and adaily meal insulin for subcutaneous therapy as an apportioning of thetotal daily dose of insulin, wherein the daily basal insulin is half ofthe total daily dose of insulin and the daily meal insulin is half ofthe total daily dose of insulin. Further, the method includes sendingthe recommended insulin does from the computing device to a subcutaneousinjection device or electronically displaying the recommended insulindoses on a display in communication with the computing device.

In some examples, when the blood glucose drops more than a thresholdpercent of its previous value, the method includes decreasing the timeinterval. This threshold percent is configured with two values: 1) alower (more sensitive) value when the blood glucose is below the lowlimit of the target range but above the hypo-threshold; and 2) a higher(less stringent) value when the blood glucose is above the low limit ofthe target range. The method may include setting the time interval to ahypoglycemia time interval of between about 15 minutes and about 30minutes when the current blood glucose measurement is below thehypo-threshold blood glucose level.

Implementations of the disclosure may include one or more of thefollowing features. In some implementations, the method determining theinsulin dose rate using the current blood glucose measurement, aconstant (e.g., 60 mg/dl), and a unit-less multiplier.

The method includes adjusting the multiplier as follows: a) multiplyingthe multiplier by a change factor when the current blood glucosemeasurement is greater than an upper limit of the blood glucose targetrange, and the ratio of the current blood glucose to the previous bloodglucose is greater than a threshold-ratio; b) dividing the multiplier bya change factor when the current blood glucose measurement is less thana lower limit of the blood glucose target range; c) re-use the previousmultiplier for two or more intervals starting at the manual initiationof a meal bolus infusion process; and d) leaving the multiplierunchanged between time intervals when none of conditions a, b, or c areapplicable.

The method includes leaving the multiplier unchanged between timeintervals when the current blood glucose measurement is greater than anupper limit of the blood glucose target range and the blood glucose droprate is greater than or equal to a threshold rate of descent, andmultiplying the multiplier by a change factor when the current bloodglucose measurement is greater than an upper limit of the blood glucosetarget range and the blood glucose drop rate is less than the thresholdrate of descent. Additionally or alternatively, the method includesdividing the multiplier by a change factor when the current bloodglucose measurement is less than a lower limit of a blood glucose targetrange and leaving the multiplier unchanged between time intervals whenthe current blood glucose measurement is within the blood glucose targetrange. In some examples, the method includes leaving the multiplierunchanged for at least two subsequent time intervals when the currentblood glucose measurement is a pre-meal measurement.

In some examples, a meal bolus infusion process allows for thecalculation of mealtime insulin for patients consuming oralcarbohydrates. These examples may include leaving the multiplierunchanged for at least two subsequent time intervals when the currentblood glucose measurement is a pre-meal measurement. In some examples,the method includes receiving, on the computing device, a number ofcarbohydrates for a meal and determining, using the computing device, ameal bolus rate based on the number of carbohydrates and an intravenousinsulin rate based on the blood glucose level. In addition, the methodincludes determining a Total Insulin Rate including the sum of the mealbolus rate and the intravenous insulin rate based on a blood glucosevalue. The method may further include setting the time interval to about30 minutes immediately following the pre-meal blood glucose and for thenext glucose measurement time interval. If the blood glucose measurementis a second consecutive measurement after an initial pre-meal bloodglucose measurement, the method includes setting the time interval toabout 60 minutes.

In some implementations, the method includes decreasing the timeinterval when the current blood glucose measurement is greater than orequal to the lower limit of the blood glucose target range and the bloodglucose drop rate exceeds a threshold drop rate. The method may alsoinclude setting the time interval to a default value of about one hourwhen the current blood glucose measurement is greater than or equal tothe lower limit of the blood glucose target range and the blood glucosedrop rate is less than or equal to a threshold drop rate. The method mayinclude setting the time interval to a hypoglycemia time interval ofbetween about 15 minutes and about 30 minutes, when the current bloodglucose measurement is below the lower limit of the blood glucose targetrange and greater than a hypo-threshold blood glucose level.

In some implementations, the method includes decreasing the timeinterval when the current blood glucose measurement is below the lowerlimit of the blood glucose target range and below the hypo-thresholdblood glucose level, and the blood glucose drop rate is less than orequal to a threshold drop rate. The method may also include setting thetime interval to a default value of about one hour when the currentblood glucose measurement is below the lower limit of the blood glucosetarget range and below the hypo-threshold blood glucose level, and theblood glucose drop rate is greater than the threshold drop rate.

In some examples, the method includes receiving, on the computingdevice, a number of carbohydrates per meal and determining, using thecomputing device, an intravenous insulin rate. In addition, the methodincludes determining, using the computing device, a meal bolus ratebased on the number of carbohydrates and the insulin dose rate based onthe intravenous insulin rate and the estimated meal bolus rate. Themethod may further include setting the time interval to about 30minutes. If the blood glucose measurement is a second consecutivemeasurement after an initial pre-meal blood glucose measurement, themethod includes setting the time interval to about 60 minutes.

In some implementations, the method includes a function to transitionthe insulin delivery method from an intravenous to subcutaneousbasal-bolus regimen. The transition method provides doses and parametersfor starting the patient on basal-bolus subcutaneous treatment. Thetransition method includes electronically displaying on a display awarning and blocking transition to a subcutaneous administration ofinsulin when the current blood glucose measurement is outside astability target range. In addition, the method includes electronicallydisplaying on the display a warning when the current blood glucosemeasurement is within the stability target range for less than athreshold stability period of time. In some examples, the methodincludes determining a total daily dose of insulin based on themultiplier when the current blood glucose measurement is within astability target range for a threshold stability period of time.

Another aspect of the disclosure includes a system for managing insulin.The system includes a glucometer measuring blood glucose measurementsseparated by a time interval, an insulin administration device, and adosing controller in communication with the glucometer and the insulinadministration device. The dosing controller includes a computing deviceand non-transitory memory in communication with the computing device.The non-transitory memory stores instructions that when executed by thecomputing device cause the computing device to perform operations. Theoperations include receiving blood glucose measurements on a computingdevice from a glucometer, the blood glucose measurements separated by atime interval. For each time interval, the system includes determining,using the computing device, an intravenous insulin infusion rate basedon the blood glucose measurements of the time interval and determining,using the computing device, a blood glucose percentage drop based on theblood glucose measurements (e.g., between a current blood glucosemeasurement and a previous blood glucose measurement). The systemfurther includes determining, using the computing device, a bloodglucose drop rate based on the blood glucose measurements and the timeinterval and decreasing the time interval between blood glucosemeasurements by the glucometer when the blood glucose percentage drop isgreater than a threshold percentage drop. The system further includesdecreasing the time interval between blood glucose measurements by theglucometer when the blood glucose drop rate is greater than a thresholddrop rate and sending the intravenous insulin infusion rate from thecomputing device to the insulin administration device.

In some implementations, the system operations further include settingthe time interval between the blood glucose measurements by theglucometer to a default time interval or a minimum of a preconfiguredhypoglycemia time interval when a current blood glucose measurement isless than a threshold hypoglycemia blood glucose value or apreconfigured short time interval. The minimum of a preconfigured shorttime interval is set when the current blood glucose measurement isgreater than the threshold hypoglycemia blood glucose value and lessthan a lower limit of a blood glucose target range and the blood glucosepercentage drop is greater than a low blood glucose percentage droplimit or the current blood glucose measurement is greater than or equalto the lower limit of the blood glucose target range and the bloodglucose percentage drop is greater than a regular blood glucosepercentage drop limit. Further, the operations include setting the timeinterval between the blood glucose measurements by the glucometer to aminimum of a preconfigured blood glucose drop rate time interval whenthe blood glucose drop rate is greater than a blood glucose drop ratelimit or a preconfigured long time interval when the blood glucosemeasurements have been within the blood glucose target range for aduration of time greater than a stable time period, or a preconfiguredmeal bolus time interval when a meal bolus program is in operation. Thepreconfigured hypoglycemia time interval is less than the short timeinterval, the short time interval is less than the blood glucose droprate time interval, the blood glucose drop rate time interval is lessthan the long time interval, and the meal bolus time interval is lessthan the long time interval.

In some examples, the operations further include leaving the multiplierunchanged between time intervals when the current blood glucosemeasurement is greater than an upper limit of a blood glucose targetrange and a ratio of the current blood glucose measurement divided by aprevious blood glucose measurement is less than or equal to a thresholdratio. The system further includes multiplying the multiplier by achange factor when the current blood glucose measurement is greater thanthe upper limit of the blood glucose target range and the ratio of thecurrent blood glucose measurement divided by the previous blood glucosemeasurement is greater than the threshold ratio. In some examples, theconstant equals 60 mg/dl and the threshold ratio is 0.85. Additionallyor alternatively, the operations may further include dividing themultiplier by the change factor when the current blood glucosemeasurement is less than a lower limit of the blood glucose targetrange. In some implementations, the operations further include, inresponse to receiving an indication of patient solid food consumption,increasing the intravenous insulin infusion rate and maintaining themultiplier unchanged for at least two time intervals.

The system may further include receiving, at the computing device, anumber of estimated grams of carbohydrates for a meal, determining,using the computing device, an estimated meal bolus in units of insulinbased on the number of estimated grams of carbohydrates and acarbohydrate-insulin-ratio and determining, using the computing device,an estimated meal bolus insulin rate, based on the estimated meal bolus,an available delivery time, and a configurable constant. The system mayalso include determining, using the computing device, a total insulinrate as a sum of the intravenous insulin rate and the estimated mealbolus insulin rate and sending the total insulin rate from the computingdevice to the insulin administration device. The system operations mayfurther include dividing a total meal time into meal time sub-intervals,a first meal time sub-interval starting with a pre-meal bolus glucosemeasurement before receiving the indication of patient solid foodconsumption and determining, using the computing device, the totalinsulin rate for each meal time sub-interval in succession.

In some examples, the operations further include receiving, at thecomputing device, a number of actual grams of carbohydrates for the mealduring a subsequent time interval after the first time interval,determining, using the computing device, an actual meal bolus based onthe number of actual grams of carbohydrates and determining a meal bolusin units of insulin, using the computing device, by subtracting aproduct of the estimated meal bolus insulin rate and an actual deliverytime from the actual meal bolus. The system may further includedetermining, using the computing device, a revised meal bolus insulinrate as the remaining meal bolus divided by a time remaining in thetotal meal time, determining, using the computing device, a revisedtotal insulin rate as a sum of the intravenous insulin rate and therevised meal bolus insulin rate and sending the revised total insulinrate from the computing device to the insulin administration device. Theoperations may further comprise decreasing the time interval to lessthan the default time interval for the one or more meal timesub-intervals.

In some implementations, the operations include electronicallydisplaying on a display in communication with the computing device awarning and blocking transition to a subcutaneous administration ofinsulin when the current blood glucose measurement is outside astability target range and electronically displaying on the display awarning when the current blood glucose measurement is within thestability target range for less than a threshold stability period oftime. In some examples, the operations include determining, using thecomputing device, a total daily dose of insulin based on the multiplierwhen the current blood glucose measurement is within a stability targetrange for a threshold stability period of time. The system also includesdetermining, using the computing device, recommended insulin doseincluding a daily basal insulin and a daily meal insulin forsubcutaneous therapy as an apportioning of the total daily dose ofinsulin, wherein the daily basal insulin is half of the total daily doseof insulin and the daily meal insulin is half of the total daily dose ofinsulin. The system may further include sending the recommended insulindose from the computing device to a subcutaneous injection device orelectronically displaying the recommended insulin doses on a display incommunication with the computing device.

The dosing controller may determine the insulin dose rate based on thecurrent blood glucose measurement, a constant (e.g., 60 mg/dl), and amultiplier. The dosing controller leaves the multiplier unchangedbetween time intervals when the current blood glucose measurement isgreater than an upper limit of the blood glucose target range and theblood glucose drop rate is greater than or equal to a threshold rate ofdescent. In addition, the dosing controller multiplies the multiplier bya change factor when the current blood glucose measurement is greaterthan an upper limit of the blood glucose target range and the bloodglucose drop rate is less the threshold rate of descent. The dosingcontroller may leave the multiplier unchanged between time intervalswhen the current blood glucose measurement is less than a lower limit ofthe blood glucose target range, and it may divide the multiplier by achange factor when the current blood glucose measurement is within theblood glucose target range. In some examples, the dosing controllerleaves the multiplier unchanged for at least two subsequent timeintervals when the current blood glucose measurement is a pre-mealmeasurement.

In some implementations, the dosing controller decreases the timeinterval when the current blood glucose measurement is greater than orequal to the lower limit of the blood glucose target range and the bloodglucose drop rate exceeds a threshold drop rate. In addition, the dosingcontroller sets the time interval to a default value of about one hourwhen the current blood glucose measurement is greater than or equal tothe lower limit of the blood glucose target range and the blood glucosedrop rate is less than or equal to a threshold drop rate. The dosingcontroller may set the time interval to a hypoglycemia time interval ofbetween about 15 minutes and about 30 minutes, when the current bloodglucose measurement is below the lower limit of the blood glucose targetrange and greater than a hypo-threshold blood glucose level.

In some examples, the dosing controller decreases the time interval whenthe current blood glucose measurement is below the lower limit of theblood glucose target range and below the hypo-threshold blood glucoselevel, and the blood glucose drop rate is less than or equal to athreshold drop rate. Moreover, the dosing controller sets the timeinterval to a default value of about one hour when the current bloodglucose measurement is below the lower limit of the blood glucose targetrange and below the hypo-threshold blood glucose level, and the bloodglucose drop rate is greater than the threshold drop rate.

In some examples, the dosing controller receives, on the computingdevice, a number of carbohydrates per meal, then determines, using thecomputing device, an intravenous insulin rate and a meal bolus ratebased on the number of carbohydrates. Furthermore, the dosing controllerdetermines, using the computing device, the insulin dose rate based onthe intravenous insulin rate and the estimated meal bolus rate. Thedosing controller may set the time interval to about 30 minutes.Additionally or alternatively, the dosing controller may set the timeinterval to about 60 minutes if the blood glucose measurement is asecond consecutive measurement after an initial pre-meal blood glucosemeasurement.

In some examples, the dosing controller electronically displays on adisplay in communication with the dosing controller a warning and blockstransition to a subcutaneous administration of insulin when the currentblood glucose measurement is outside a stability target range. Thedosing controller electronically displays on the display a warning whenthe current blood glucose measurement is within the stability targetrange for less than a threshold stability period of time. The dosingcontroller may determine a total daily dose of insulin based on themultiplier when the current blood glucose measurement is within astability target range for a threshold stability period of time.

The details of one or more implementations of the disclosure are setforth in the accompanying drawings and the description below. Otheraspects, features, and advantages will be apparent from the descriptionand drawings, and from the claims.

DESCRIPTION OF DRAWINGS

FIG. 1A is a schematic view of an exemplary system for monitoring bloodglucose level of a patient.

FIG. 1B is a schematic view of an exemplary system for monitoring bloodglucose level of a patient.

FIG. 2A is a schematic view of an exemplary process for monitoring theblood glucose level of a patient.

FIG. 2B is a schematic view of an exemplary display for inputtingpatient information.

FIG. 2C is a schematic view of an exemplary display for selecting apatient from a list of patients.

FIG. 2D is a schematic view of an exemplary display indicating initialintravenous dosing information.

FIG. 3 is a schematic view of an exemplary dose calculation process ofFIG. 2A.

FIG. 4A is a schematic view of an exemplary calculation of theintravenous time interval of FIG. 2A.

FIGS. 4B and 4C are schematic views of an exemplary display showing thetime a next blood glucose measurement is due.

FIG. 4D is a schematic view of an exemplary display for inputtingpatient information.

FIG. 4E is a schematic view of an exemplary display of patientinformation and a timer for a patient's next blood glucose measurement.

FIGS. 5A and 5B are schematic views of an exemplary meal bolus processof FIG. 2A.

FIG. 5C is a schematic view of an exemplary display for inputting apatient's blood glucose measurement.

FIG. 5D is a schematic view of an exemplary display of patientinformation and a timer for a patient's next blood glucose measurement.

FIGS. 5E and 5F are schematic views of exemplary displays requestinginformation from the user.

FIGS. 6A and 6B are schematic views of an exemplary subcutaneoustransition process of FIG. 2A.

FIG. 6C is a schematic view of an exemplary warning to the user relatingto the patient.

FIG. 6D is a schematic view of an exemplary display inquiring whetherthe patient should continue treatment or stop.

FIG. 6E is a schematic view of an exemplary display requestinginformation from the user relating to the patient.

FIG. 6F is a schematic view of an exemplary display showing therecommended dose of insulin.

FIG. 6G is a schematic view of an exemplary view to the user relating totransitioning a patient to subcutaneous delivery.

FIG. 7 is a schematic view of an exemplary arrangement of operations foradministering insulin.

Like reference symbols in the various drawings indicate like elements.

DETAILED DESCRIPTION

Diabetic hospital patients who eat meals often have poor appetites;consequently, co-ordination of meal boluses and meals is difficult. Mealboluses without meals cause hypoglycemia; meals without meal bolusescause hyperglycemia. Different providers may use different methods ofadjusting doses: some may use formulas of their own; some may use paperprotocols that are complex and difficult for the nurse to follow,leading to a high incidence of human error; and some may use heuristicmethods. There is no guarantee of consistency. Moreover, for diabeticpatients who do not eat meals, there is no currently no computerizedmethod of tracking the patient's status. For non-diabetic patient whoget include due to “stress hyperglycemia” when they are very sick orundergoing surgery, there is no current method of monitoring theirrecovery when the stress subsides and their need for insulin rapidlydecreases. If the dose regimen does not decrease rapidly also,hypoglycemia may result. Therefore, it is desirable to have a clinicalsupport system 100 (FIGS. 1A and 1B) that monitors patients' bloodglucose level.

Referring to FIGS. 1A and 1B, in some implementations, a clinicaldecision support system 100 analyzes inputted patient conditionparameters for a patient 10 and calculates a personalized dose ofinsulin to bring and maintain the patient's blood glucose level into atarget range BG_(TR). Moreover, the system 100 monitors the glucoselevels of a patient 10 and calculates recommended intravenous orsubcutaneous insulin dose to bring the patient's blood glucose into thepreferred target range BG_(TR) over a recommended period of time. Aqualified and trained healthcare professional 40 may use the system 100along with clinical reasoning to determine the proper dosingadministered to a patient 10. Therefore, the system 100 is a glycemicmanagement tool for evaluation a patient's current and cumulative bloodglucose value BG while taking into consideration the patient'sinformation such as age, weight, and height. The system 100 may alsoconsider other information such as carbohydrate content of meals,insulin doses being administered to the patient 10, e.g., long-actinginsulin doses for basal insulin and rapid-acting insulin doses for mealboluses and correction boluses. Based on those measurements (that may bestored in non-transitory memory 24, 114, 144), the system 100 recommendsan intravenous dosage of insulin, glucose, or saline or a subcutaneousbasal and bolus insulin dosing recommendation or prescribed dose toadjust and maintain the blood glucose level towards a configurable(based on the patient's information) physician's determined bloodglucose target range BG_(TR). The system 100 also considers a patient'sinsulin sensitivity or improved glycemic management and outcomes. Thesystem 100 may take into account pertinent patient information such asdemographics and previous results, leading to a more efficient use ofhealthcare resources. Finally, the system 100 provides a reportingplatform for reporting the recommendations or prescribed dose(s) to theuser 40 and the patient 10. In addition, for diabetic patients who eatmeals, the system 100 provides faster, more reliable, and more efficientinsulin administration than a human monitoring the insulinadministration. The system 100 reduces the probability of human errorand insures consistent treatment, due to the system's capability ofstoring and tracking the patient's blood glucose levels BG, which may beused for statistical studies. As for patients who are tube-fed or do noteat meals, the system 100 provides dedicated subprograms, which in turnprovide basal insulin and correction boluses but no meal boluses.Patients who are tube-fed or who do not eat usually have a higher basalinsulin level than patients who eat, because the carbohydrates in thenutritive formula are accounted-for in the basal insulin. The system 100provides a meal-by-meal adjustment of Meal Boluses without carbohydratecounting, by providing a dedicated subprogram that adjusts meal bolusesbased on the immediately preceding meal bolus and the BG that followedit. The system 100 provides a meal-by-meal adjustment of Meal Boluseswith carbohydrate counting by providing a dedicated subprogram thatadjusts meal boluses based a Carbohydrate-to-Insulin Ratio (CIR) that isadjusted at each meal, based on the CIR used at the immediatelypreceding meal bolus and the BG that followed it.

Hyperglycemia is a condition that exists when blood sugars are too high.While hyperglycemia is typically associated with diabetes, thiscondition can exist in many patients who do not have diabetes, yet haveelevated blood sugar levels caused by trauma or stress from surgery andother complications from hospital procedures. Insulin therapy is used tobring blood sugar levels back into a normal range.

Hypoglycemia may occur at any time when a patient's blood glucose levelis below a preferred target. Appropriate management of blood glucoselevels for critically ill patients reduces co-morbidities and isassociated with a decrease in infection rates, length of hospital stay,and death. The treatment of hyperglycemia may differ depending onwhether or not a patient has been diagnosed with Type 1 diabetesmellitus, Type 2 diabetes mellitus, gestational diabetes mellitus, ornon-diabetic stress hyperglycemia. The blood glucose target rangeBG_(TR) is defined by a lower limit, i.e., a low target BG_(TRL) and anupper limit, i.e., a high target BG_(TRH).

Stress-related hyperglycemia: Patients often get “stress hyperglycemia”if they are very sick or undergoing surgery. This condition requiresinsulin. In diabetic patients, the need for insulin is visiblyincreased. In non-diabetic patients, the stress accounts for the onlyneed for insulin, and as the patients recover, the stress subsides, andtheir need for insulin rapidly decreases. For non-diabetic patients, theconcern is that their need for insulin decreases faster than their doseregimen, leading to hypoglycemia.

Diabetes Mellitus has been treated for many years with insulin. Somerecurring terms and phrases are described below:

Injection: Administering insulin by means of manual syringe or aninsulin “pen,” with a portable syringe named for its resemblance to thefamiliar writing implement.

Infusion: Administering insulin in a continuous manner by means of aninsulin pump for subcutaneous insulin or an intravenous apparatus 123 a,both of which are capable of continuous administration.

Intravenous Insulin Therapy: Intravenous infusion of insulin has beenapproved by the U.S. Food and Drug Administration as an acceptableindication for use. Intravenous infusion is the fastest of all insulinadministration routes and, typically, only available in the hospitalsetting. For instance, in intensive care units, the patients may be fedby intravenous glucose infusion, by intravenous Total ParenteralNutrition (TPN), or by a tube to the stomach. Patients are often giveninsulin in an intravenous infusion at an insulin infusion rate IIR. TheIIR is regulated by the frequent testing of blood glucose, typically atintervals between about 20 minutes and 2 hours. This is combined with aprotocol in which a new IIR is computed after each blood glucose test.

Basal-Bolus Therapy: Basal-bolus therapy is a term that collectivelyrefers to any insulin regimen involving basal insulin and boluses ofinsulin.

Basal Insulin: Insulin that is intended to metabolize the glucosereleased by a patient's the liver during a fasting state. Basal insulinis administered in such a way that it maintains a background level ofinsulin in the patient's blood, which is generally steady but may bevaried in a programmed manner by an insulin pump 123 a. Basal insulin isa slow, relatively continuous supply of insulin throughout the day andnight that provides the low, but present, insulin concentrationnecessary to balance glucose consumption (glucose uptake and oxidation)and glucose production (glucogenolysis and gluconeogenesis). A patient'sBasal insulin needs are usually about 10 to 15 mU/kg/hr and account for30% to 50% of the total daily insulin needs; however, considerablevariation occurs based on the patient 10.

Bolus Insulin: Insulin that is administered in discrete doses. There aretwo main types of boluses, Meal Bolus and Correction Bolus.

Meal Bolus: Taken just before a meal in an amount which is proportionalto the anticipated immediate effect of carbohydrates in the mealentering the blood directly from the digestive system. The amounts ofthe Meal Boluses may be determined and prescribed by a physician 40 foreach meal during the day, i.e., breakfast, lunch, and dinner.Alternatively, the Meal Bolus may be calculated in an amount generallyproportional to the number of grams of carbohydrates in the meal. Theamount of the Meal Bolus is calculated using a proportionality constant,which is a personalized number called the Carbohydrate-to-Insulin Ratio(CIR) and calculated as follows:Meal Insulin Bolus={grams of carbohydrates in the meal}/CIR  (1)

Correction Bolus CB: Injected immediately after a blood glucosemeasurement; the amount of the correction bolus is proportional to theerror in the BG (i.e., the bolus is proportional to the differencebetween the blood glucose measurement BG and the patient's personalizedTarget blood glucose BG_(Target)). The proportionality constant is apersonalized number called the Correction Factor, CF, and is calculatedas follows:CB=(BG−BG_(Target))/CF  (2)

A Correction Bolus CB is generally administered in a fasting state,after the previously consumed meal has been digested. This oftencoincides with the time just before the next meal.

There are several kinds of Basal-Bolus insulin therapy including InsulinPump therapy and Multiple Dose Injection therapy:

Insulin Pump Therapy: An insulin pump 123 a is a medical device used forthe administration of insulin in the treatment of diabetes mellitus,also known as continuous subcutaneous insulin infusion therapy. Thedevice includes: a pump, a disposable reservoir for insulin, and adisposable infusion set. The pump 123 a is an alternative to multipledaily injections of insulin by insulin syringe or an insulin pen andallows for intensive insulin therapy when used in conjunction with bloodglucose monitoring and carbohydrate counting. The insulin pump 123 a isa battery-powered device about the size of a pager. It contains acartridge of insulin, and it pumps the insulin into the patient via an“infusion set”, which is a small plastic needle or “canula” fitted withan adhesive patch. Only rapid-acting insulin is used.

Multiple Dose Injection (MDI): MDI involves the subcutaneous manualinjection of insulin several times per day using syringes or insulinpens 123 b. Meal insulin is supplied by injection of rapid-actinginsulin before each meal in an amount proportional to the meal. Basalinsulin is provided as a once, twice, or three time daily injection of adose of long-acting insulin. Other dosage frequencies may be available.Advances continue to be made in developing different types of insulin,many of which are used to great advantage with MDI regimens:

Long-acting insulins are non-peaking and can be injected as infrequentlyas once per day. These insulins are widely used for Basal Insulin. Theyare administered in dosages that make them appropriate for the fastingstate of the patient, in which the blood glucose is replenished by theliver to maintain a steady minimum blood glucose level.

Rapid-acting insulins act on a time scale shorter than natural insulin.They are appropriate for boluses.

In some examples, critically ill patients are ordered nil per os (NPO),which means that oral food and fluids are withheld from the patient 10.Typically these patients 10 are unconscious, have just completed aninvasive surgical procedure, or generally have difficulty swallowing.Intravenous insulin infusion is typically the most effective method ofmanaging blood glucose levels in these patients. A patient 10 may be NPOand receiving a steady infusion of intravenous glucose, Total ParenteralNutrition, tube feeding, regular meals that include carbohydrates, ornot receiving any nutrition at all. In cases where the patient 10 is notreceiving any nutrition, blood glucose is typically replaced byendogenous production by the liver.

As a patient's condition improves, an NPO order may be lifted, allowingthe patient 10 to commence an oral caloric intake. In patients 10 withglycemic abnormalities, additional insulin may be needed to cover theconsumption of carbohydrates. These patients 10 generally receiveone-time injections of insulin in the patient's subcutaneous tissue.

Subcutaneous administration of mealtime insulin in critically illpatients 10 can introduce a patient safety risk if, after receiving theinsulin injection, the patient 10 decides not to eat, is unable tofinish the meal, or experiences emesis.

Continuous intravenous infusion of mealtime insulin, over apredetermined time interval, allows for an incremental fulfillment ofthe patient's mealtime insulin requirement, while minimizing patientsafety risks. If a patient 10 decides he/she is unable to eat, thecontinuous intravenous infusion may be stopped or, if a patient 10 isunable to finish the meal, the continuous intravenous infusion rate maybe decreased to compensate for the reduction in caloric intake.

The pharmacokinetics (what the body does to a drug over a period oftime, which includes the processes of absorption, distribution,localization in tissues, biotransformation, and excretion) andpharmacodynamics (what a drug does to the body) actions of insulinsignificantly improve when administering insulin via an intravenousroute, which is a typical method of delivery for hospitalized patients10. The management of prandial insulin requirements using an intravenousroute can improve patient safety, insulin efficiency, and the accuracyof insulin dosing. The majority of patients who require continuousintravenous insulin infusion therapy may also need to be transitioned toa subcutaneous insulin regimen for ongoing control of blood glucose,regardless of diabetes mellitus (DM) diagnosis. Moreover, the timing,dosing, and process to transition patients 10 from a continuousintravenous route of insulin administration to a subcutaneous insulinregimen is complex and should be individualized based on various patientparameters. Failure to individualize this approach could increase therisk of severe hypoglycemia during the transition process. If not enoughinsulin is given, the patient 10 may experience acute post-transitionhyperglycemia, requiring re-initiation of a continuous intravenousinsulin infusion. Therefore, the clinical decision support system 100calculates a personalized dose of insulin to bring and maintain thepatient's blood glucose level into a target range BG_(TR), while takinginto consideration the condition of the patient 10.

The clinical decision support system 100 includes a glycemic managementmodule 50, an integration module 60, a surveillance module 70, and areporting module 80. Each module 50, 60, 70, 80 is in communication withthe other modules 50, 60, 70, 80 via a network 20. In some examples, thenetwork 24 (discussed below) provides access to cloud computingresources that allows for the performance of services on remote devicesinstead of the specific modules 50, 60, 70, 80. The glycemic managementmodule 50 executes a process 200 (e.g., an executable instruction set)on a processor 112, 132, 142 or on the cloud computing resources. Theintegration module 60 allows for the interaction of users 40 with thesystem 100. The integration module 60 receives information inputted by auser 40 and allows the user 40 to retrieve previously inputtedinformation stored on a storage system (e.g., one or more of cloudstorage resources 24, a non-transitory memory 144 of a hospital'selectronic medical system 140, a non-transitory memory 114 of thepatient device 110, or other non-transitory storage media incommunication with the integration module 60). Therefore, theintegration module 60 allows for the interaction between the users 40and the system 100 via a display 116, 146. The surveillance module 70considers patient information 208 a received from a user 40 via theintegration module 60 and information received from a glucometer 124that measures a patient's blood glucose value BG and determines if thepatient 10 is within a threshold blood glucose value BG_(TH). In someexamples, the surveillance module 70 alerts the user 40 if a patient'sblood glucose values BG are not within a threshold blood glucose valueBG_(TH). The surveillance module 70 may be preconfigured to alert theuser 40 of other discrepancies between expected values and actual valuesbased on pre-configured parameters (discussed below). For example, whena patient's blood glucose value BG drops below a lower limit of thethreshold blood glucose value BG_(THL). The reporting module 80 may bein communication with at least one display 116, 146 and providesinformation to the user 40 determined using the glycemic managementmodule 50, the integration module 60, and/or the surveillance module 70.In some examples, the reporting module 80 provides a report that may bedisplayed on a display 116, 146 and/or is capable of being printed.

The system 100 is configured to evaluate a glucose level and nutritionalintake of a patient 10. The system 100 also evaluates whether thepatient 10 is transitioning to a subcutaneous insulin regime. Based onthe evaluation and analysis of the data, the system 100 calculates aninsulin dose, which is administered to the patient 10 to bring andmaintain the blood glucose level of the patient 10 into the bloodglucose target range BG_(TR). The system 100 may be applied to variousdevices, including, but not limited to, intravenous infusion pumps 123a, subcutaneous insulin infusion pumps 123 a, glucometers, continuousglucose monitoring systems, and glucose sensors. In someimplementations, as the system 100 is monitoring the patient's bloodglucose values BG and the patient's insulin intake, the system 100notifies the user 40 if the patient 10 receives more than 500 units/hourof insulin because the system 100 considers these patients 10 to beinsulin resistant.

In some examples the clinical decision support system 100 includes anetwork 20, a patient device 110, a dosing controller 160, and a serviceprovider 130. The patient device 110 may include, but is not limited to,desktop computers or portable electronic device (e.g., cellular phone,smartphone, personal digital assistant, barcode reader, personalcomputer, or a wireless pad) or any other electronic device capable ofsending and receiving information via the network 20.

The patient device 110 includes a data processor 112 (e.g., a computingdevice that executes instructions), and non-transitory memory 114 and adisplay 116 (e.g., touch display or non-touch display) in communicationwith the data processor 112. In some examples, the patient device 110includes a keyboard 118, speakers 212, microphones, mouse, and a camera.

The service provider 130 may include a data processor 132 incommunication with non-transitory memory 134. The service provider 130provides the patient 10 with a process 200 (see FIG. 2) (e.g., a mobileapplication, a web-site application, or a downloadable program thatincludes a set of instructions) executable on a processor 112, 132, 142of the dosing controller 160 and accessible through the network 20 viathe patient device 110, intravenous infusion pumps 123 a, hospitalelectronic medical record systems 140, or portable blood glucosemeasurement devices 124 (e.g., glucose meter or glucometer). Intravenousinfusion pumps infuse fluids, medication or nutrients into a patient'scirculatory system. Intravenous infusion pumps 123 a may be usedintravenously and, in some instances, subcutaneous, arterial andepidural infusions are used. Intravenous infusion pumps 123 a typicallyadminister fluids that are expensive or unreliable if administeredmanually (e.g., using a pen 123 b) by a nurse or doctor 40. Intravenousinfusion pumps 123 a can administer a 0.1 ml per hour injection,injections every minute, injections with repeated boluses requested bythe patient, up to a maximum number per hours, or fluids whose volumesvary by the time of day.

In some implementations, an electronic medical record system 140 islocated at a hospital 42 (or a doctor's office) and includes a dataprocessor 142, a non-transitory memory 144, and a display 146 (e.g.,touch display or non-touch display). The transitory memory 144 and thedisplay 146 are in communication with the data processor 142. In someexamples, the hospital electronic medical system 140 includes a keyboard148 in communication with the data processor 142 to allow a user 40 toinput data, such as patient information 208 a (FIGS. 2A and 2B). Thenon-transitory memory 144 maintains patient records capable of beingretrieved, viewed, and, in some examples, modified and updated byauthorized hospital personal on the display 146.

The dosing controller 160 is in communication with the glucometer 124and includes a computing device 112, 132, 142 and non-transitory memory114, 134, 144 in communication with the computing device 112, 132, 142.The dosing controller 160 executes the process 200. The dosingcontroller 160 stores patient related information retrieved from theglucometer 124 to determine an insulin dose rate IRR based on thereceived blood glucose measurement BG.

The network 20 may include any type of network that allows sending andreceiving communication signals, such as a wireless telecommunicationnetwork, a cellular telephone network, a time division multiple access(TDMA) network, a code division multiple access (CDMA) network, Globalsystem for mobile communications (GSM), a third generation (3G) network,fourth generation (4G) network, a satellite communications network, andother communication networks. The network 20 may include one or more ofa Wide Area Network (WAN), a Local Area Network (LAN), and a PersonalArea Network (PAN). In some examples, the network 20 includes acombination of data networks, telecommunication networks, and acombination of data and telecommunication networks. The patient device110, the service provider 130, and the hospital electronic medicalrecord system 140 communicate with each other by sending and receivingsignals (wired or wireless) via the network 20. In some examples, thenetwork 20 provides access to cloud computing resources, which may beelastic/on-demand computing and/or storage resources 24 available overthe network 20. The term ‘cloud’ services generally refers to a serviceperformed not locally on a user's device, but rather delivered from oneor more remote devices accessible via one or more networks 20.

Referring to FIGS. 1B and 2A-2C, the process 200 receives parameters(e.g., patient condition parameters) inputted via the client device 110,the service provider 130, and/or the hospital system 140, analyzes theinputted parameters, and determines a personalized dose of insulin tobring and maintain a patient's blood glucose level BG into a preferredtarget range BG_(TR).

In some implementations, before the process 200 begins to receive theparameters, the process 200 may receive a username and a password (e.g.,at a login screen displayed on the display 116, 146) to verify that aqualified and trained healthcare professional 40 is initiating theprocess 200 and entering the correct information that the process 200needs to accurately administer insulin to the patient 10. The system 100may customize the login screen to allow a user 40 to reset theirpassword and/or username. Moreover, the system 100 may provide a logoutbutton (not shown) that allows the user 40 to log out of the system 100.The logout button may be displayed on the display 116, 146 at any timeduring the execution of the process 200.

The clinical decision support system 100 may include an alarm system 120that alerts a user 40 when the patient's blood glucose level BG isoutside the target range BG_(TR). The alarm system 120 may produce anaudible sound via speaker 122 in the form of a beep or some like audiosounding mechanism. In some examples, the alarm system 120 displays awarning message or other type of indication on the display 116 of thepatient device 110 to provide a warning message. The alarm system 120may also send the audible and/or visual notification via the network 20to the hospital system 140 (or any other remote station) for display onthe display 146 of the hospital system 140 or played through speakers152 of the hospital system 140.

The process 200 prompts a user 40 to input patient information 208 a atblock 208. The user 40 may input the patient information 208 a, forexample, via the user device 110 or via the hospital electronic medicalrecord systems 140 located at a hospital 42 (or a doctor's office). Theuser 40 may input new patient information 208 a as shown in FIG. 2B orretrieve previously stored patient information 208 a as shown in FIG.2C. In some implementations, the process 200 provides the user 40 with apatient list 209 (FIG. 2C) where the user 40 selects one of the patientnames from the patient list 209, and the process 200 retrieves thatpatient's information 208 a. The process 200 may allow the user 40 tofiler the patient list 209, e.g., alphabetically (first name or lastname), by location, patient identification. The process 200 may retrievethe patient information 208 a from the non-transitory memory 144 of thehospital's electronic medical system 140 or the non-transitory memory114 of the patient device 110 (e.g., where the patient information 208 awas previously entered and stored). The patient information 208 a mayinclude, but is not limited to, a patient's name, a patient'sidentification number (ID), a patient's height, weight, date of birth,diabetes history, physician name, emergency contact, hospital unit,diagnosis, gender, room number, and any other relevant information. Insome examples, the diagnosis may include, but is not limited to, burnpatients, Coronary artery bypass patients, stoke patients, diabeticketoacidosis (DKA) patients, and trauma patients. After the user 40completes inputting the patient information 208 a, the process 200 atblock 202 determines whether the patient 10 is being treated with anintravenous treatment module by prompting the user 40 (e.g., on thedisplay 116, 146) to input whether the patient 10 will be treated withan intravenous treatment module. If the patient 10 will not be treatedwith the intravenous treatment module, the process 200 determines atblock 210 whether the patient 10 will be treated with a subcutaneoustreatment module, by asking the user 40 (e.g., by prompting the user 40on the display 116, 146). If the user 40 indicates that the patient 10will be treated with the subcutaneous treatment, the process 200 flowsto block 216, where the user 40 enters patient subcutaneous information216 a, such as bolus insulin type, target range, basal insulin type andfrequency of distribution (e.g., 1 does per day, 2 doses per day, 3doses per day, etc.), patient diabetes status, subcutaneous type orderedfor the patient (e.g., Basal/Bolus and correction that is intended forpatients on a consistent carbohydrate diet, or Basal and correction thatis intended for patients who are NPO or on continuous enteral feeds),frequency of patient blood glucose measurements, or any other relevantinformation. In some implementations, the patient subcutaneousinformation 216 a is prepopulated with default parameters, which may beadjusted or modified. When the user 40 enters the patient subcutaneousinformation 216, the subcutaneous program begins at block 226. Theprocess may determine whether the patient 10 is being treated with anintravenous treatment or a subcutaneous treatment by prompting the user40 to select between two options (e.g., a button displayed on thedisplay 116, 146), one being the intravenous treatment and the otherbegin the subcutaneous treatment.

In some implementations and referring back to block 202, if the process200 determines that the patient 10 will be treated with the intravenoustreatment module, the process 200 prompts the user 40 at block 204 forsetup data 204 a, such as patient parameters 204 a relevant to theintravenous treatment mode. In some examples, the patient parameter 204a relating to the intravenous treatment may be prepopulated, forexample, with default values that may be adjusted and modified by theuser 40. These patient parameters 204 a may include an insulinconcentration (i.e., the strength of insulin being used for theintravenous dosing, which may be measured in units/milliliter), the typeof insulin and rate being administered to the patient, the blood glucosetarget range BG_(TR), the patient's diabetes history, a number ofcarbohydrates per meal, or any other relevant information. In someimplementations, the type of insulin and the rate of insulin depend onthe BG of the patient 10. For example, the rate and type of insulinadministered to a patient 10 when the blood glucose value BG of thepatient 10 is greater or equal to 250 mgl/dl may be different than therate and type of insulin administered to the patient 10 when the bloodglucose value BG of the patient is greater than 250 ml/dl. The bloodglucose target range BG_(TR) may be a configurable parameter, customizedbased on various patient factors. The blood glucose target range BG_(TR)may be limited to 40 mg/dl (e.g., 100-140 mg/dl, 140-180 mg/dl, and120-160 mg/dl).

After the user 40 inputs patient parameters 204 a for the intravenoustreatment at block 204, the process 200 prompts the user 40 to input theblood glucose value BG of the patient 10 at block 206. The blood glucosevalue BG may be manually inputted by the user 40, sent via the network20 from a glucometer 124, sent electronically from the hospitalinformation or laboratory system 140, or other wireless device. Theprocess 200 determines a personalized insulin dose rate, referred to asan insulin infusion rate IIR, using the blood glucose value BG of thepatient 10 and a dose calculation process 300.

FIG. 3 provides a dose calculation process 300 for calculating theinsulin infusion rate IIR of the patient 10 for intravenous treatmentafter the process 200 receives the patient information 208 a discussedabove (including the patients' blood glucose value BG). At block 301 thedose calculation process 300 determines if the patient's blood glucoseBG is less than a stop threshold value BG_(THstop). If not, then atblock 303 the dose calculation process 300 goes to block 304 withouttaking any action. If, however, the patient's blood glucose BG is lessthan a stop threshold value BG_(THstop), then the calculation doseprocess sets the patient's regular insulin dose rate IRR to zero atblock 302, which then goes to block 322. The dose calculation process300 determines at decision block 304 if the inputted blood glucose valueBG is the first inputted blood glucose value.

The patient's regular insulin dose rate IIR is calculated at block 320in accordance with the following equation:IIR=(BG−K)*M  (3A)where K is a constant, known as the Offset Target, with the same unit ofmeasure as blood glucose and M is a unit-less multiplier. In someexamples, the Offset Target K is lower than the blood glucose targetrange of the patient 10. The Offset Target K allows the dose calculationprocess 300 to calculate a non-zero stable insulin dose rate even with ablood glucose result is in the blood glucose target range BG_(TR).

The initial multiplier M_(I), determined by the physician 40,approximates the sensitivity of a patient 10 to insulin. For example,the initial multiplier equals 0.02 for adults ages 18 and above. In someexamples, the initial multiplier M_(I) equals 0.01 for frail elderlypatients 10 who may be at risk for complications arising when theirblood glucose level BG falls faster than 80 mg/dl/hr. Moreover, thephysician 40 may order a higher initial multiplier M_(I) for patients 10with special needs, such as CABG patients (i.e., patients who haveundergone coronary artery bypass grafting) with BMI (Body Mass Indexwhich is a measure for the human body shape based on the individual'smass and height) less than 30 might typically receive an initialmultiplier of 0.05, whereas a patient 10 with BMI greater than 30 mightreceive an initial multiplier M_(I) of 0.06. In addition, a patient'sweight may be considered in determining the value of the initialmultiplier M_(I), for examples, in pediatric treatments, the system 100calculates a patient's initial multiplier M_(I) using the followingequation:M _(I)=0.0002×Weight of patient (in kilograms)  (3B)In some implementations, K is equal to 60 mg/dl. The dose calculationprocess 300 determines the target blood glucose target range BG_(TR)using two limits inputted by the user 40, a lower limit of the targetrange BG_(TRL) and an upper (high) limit of the target range BG_(TRH).These limits are chosen by the user 40 so that they contain the desiredblood glucose target as the midpoint. Additionally, the Offset Target Kmay be calculated dynamically in accordance with the following equation:K=BG_(Target)−Offset,  (4)where BG_(Target) is the midpoint of the blood glucose target rangeBG_(TR) and Offset is the preconfigured distance between the targetcenter BG_(Target) and the Offset Target, K.

In some implementations, the insulin dose rate IRR may be determined bythe following process on a processor 112, 132, 142. Other processes mayalso be used.

 function IIR($sf, $current_bg, $bg_default = 60,$insulin_concentration, $ins_units_of_measure = ‘units/hr’) {  settype($sf,‘float’);   settype($bg_default,‘float’);  settype($current_bg,‘float’);  settype($insulin_concentration,‘float’);   /*    @param $sf =sensitivity factor from db    @param $current_bg = the current bg valuebeing submitted    @param $db_default = the default “Stop Insulin When”value....If it isn't passed, it defaults to 60    @param$insulin_concentration = the default insulin concentration from settings  */   if($current_bg > 60) {    $iir = array( );    $iir[0] =round(($current_bg − $bg_default) * $sf, 1);    if($ins_units_of_measure != ‘units/hr’) {     $iir[1] = round(($current_bg− $bg_default) * $sf / $insulin_concentration ,1);    }    return $iir;  } else {    return 0;   }  }

Referring to decision block 304, when the dose calculation process 300determines that the inputted blood glucose value BG is the firstinputted blood glucose value, then the dose calculation process 300defines the value of the current multiplier M equal to an initialmultiplier (A) at block 306. The dose calculation process 300 thencalculates, at block 320, the Insulin Infusion Rate in accordance withthe IIR equation (EQ. 3A) and returns to the process 200 (see FIG. 2).

However, referring back to decision block 304, when the dose calculationprocess 300 determines that the inputted blood glucose value BG is notthe first inputted blood glucose value, the dose calculation process 300determines if the Meal Bolus Module has been activated at decision block308. If the dose calculation process 300 determines that the Meal BolusModule has been activated, then the dose calculation process 300 beginsa Meal Bolus process 500 (see FIG. 5).

Referring back to decision block 308, if the Meal Bolus Module has notbeen activated, the dose calculation process 300 determines, at decisionblock 310, if the current blood glucose value BG is greater than theupper limit BG_(TRH) of the blood glucose target range BG_(TR). If theblood glucose value BG is greater than the upper limit BG_(TRH) of theblood glucose target range BG_(TR), the dose calculation process 300determines, at block 314, a ratio of the current blood glucose value BGto the previous blood glucose value BG_(P), where BG_(P) was measured atan earlier time than the current BG. The process 200 then determines ifthe ratio of the blood glucose to the previous blood glucose, BG/BG_(P),is greater than a threshold value L_(A), as shown in the followingequation:(BG/BG_(P))>L _(A)  (5)where BG is the patient's current blood glucose value; BG_(P) is thepatient's previous blood glucose value; and L_(A) is the threshold ratioof BG/BG_(P) for blood glucose values above the upper limit of the bloodglucose target range BG_(TRH). If the ratio BG/BG_(P) exceeds thethreshold ratio L_(A), then the Multiplier M is increased. In someexamples, the threshold ratio L_(A) equals 0.85.

If the dose calculation process 300 determines that the ratio(BG/BG_(P)) of the blood glucose value BG to the previous blood glucosevalue BG_(P) is not greater than the threshold ratio L_(A) for a bloodglucose value BG above the upper limit BG_(TRH) of the blood glucosetarget range BG_(TR), then the dose calculation process 300 sets thevalue of the current multiplier M to equal the value of the previousmultiplier M_(P), see block 312.M=M _(P)  (6)

Referring back to block 314, if the dose calculation process 300determines that the ratio (BG/BG_(P)) of the blood glucose value BG tothe previous blood glucose BG_(P) is greater than the threshold ratioL_(A) for a blood glucose value above upper limit BG_(TRH) of the bloodglucose target range BG_(TR), then dose calculation process 300multiplies the value of the current multiplier M by a desired MultiplierChange Factor (M_(CF)) at block 318. The dose calculation process 300then calculates the insulin infusion rate at block 320 using the IIRequation (EQ. 3A) and returns to the process 200 (see FIG. 2).

Referring back to block 310, when the dose calculation process 300determines that the current blood glucose value BG is not greater thanthe upper limit BG_(TRH) of the blood glucose target range BG_(TR), thedose calculation process 300 then determines if the current bloodglucose concentration BG is below the lower limit BG_(TRL) of the bloodglucose target range BG_(TR) at decision block 311. If the current bloodglucose value BG is below the lower limit BG_(TRL) of the blood glucosetarget range BG_(TR), the dose calculation process 300 at block 316divides the value of the current multiplier M by the Multiplier ChangeFactor (M_(CF)), in accordance with the following equation:M=M _(P) /M _(CF)  (7)and calculates the current insulin infusion rate IIR using equation 3 atblock 320 and returns to the process 200 (see FIG. 2).

At block 311, if the dose calculation process 300 determines that theblood glucose value BG is not below the lower limit of the blood glucosetarget range BG_(TRL), the dose calculation process 300 sets the valueof the current multiplier to be equal to the value of the previousmultiplier M_(P) at block 312 (see EQ. 6).

Referring again to FIG. 3, at block 311, if the current blood glucosevalue BG is below the lower limit of the target range BG_(TRL), logicpasses to decision block 322, where the process 300 determines if thecurrent blood glucose concentration BG is below a hypoglycemia thresholdBG_(Hypo). If the current blood glucose BG is below the hypoglycemiathreshold BG_(Hypo), logic then passes to block 324, where the process300 recommends hypoglycemia treatment, either by a calculation of anindividualized dose of intravenous glucose or oral hypoglycemiatreatment.

Referring back to FIG. 2A, after the dose calculation process 300calculates the insulin infusion rate IIR, the process 200 proceeds to atime calculation process 400 (FIG. 4A) for calculating a time intervalT_(Next) until the next blood glucose measurement.

FIG. 4A shows the time interval calculation process 400 for calculatinga time interval T_(Next) between the current blood glucose measurementBG and the next blood glucose measurement BG_(next). The time-durationof blood glucose measurement intervals T_(Next) may vary and thestarting time interval can either be inputted by a user 40 at thebeginning of the process 200, 300, 400, or defaulted to a predeterminedtime interval, T_(Default) (e.g., one hour). The time interval T_(Next)is shortened if the blood glucose concentration BG of the patient 10 isdecreasing excessively, or it may be lengthened if the blood glucoseconcentration BG of the patient 10 becomes stable within the bloodglucose target range BG_(TR).

The time-interval calculation process 400 determines a value for thetime interval T_(Next) based on several conditions. The time-intervalprocess 400 checks for the applicability of several conditions, whereeach condition has a value for T_(next) that is triggered by alogic-test (except T_(default)). The process 400 selects the lowestvalue of T_(next) from the values triggered by logic tests (not countingT_(default)). If no logic test was triggered, the process selectsT_(default). This is accomplished in FIG. 4A by the logic structure thatselects the lowest values of T_(next) first. However, other logicstructures are possible as well.

The time calculation process 400 determines at decision block 416 if thecurrent blood glucose BG is below the lower limit BG_(TRL) (target rangelow limit) of the blood glucose target range BG_(TR). If the currentblood glucose BG is below the lower limit BG_(TRL) of the blood glucosetarget range BG_(TR), then the time calculation process 400 determines,at decision block 418, if the current blood glucose BG is less than ahypoglycemia-threshold blood glucose level BG_(Hypo).

If the current blood glucose BG is less than the hypoglycemia-thresholdblood glucose level BG_(Hypo) the time calculation process 400 sets thetime interval T_(Next) to a hypoglycemia time interval T_(Hypo), e.g.,15 or 30 minutes, at block 426. Then the time calculation process 400 iscomplete and returns to the process 200 (FIG. 2) at block 428.

If the current blood glucose BG is not less than (i.e., is greater than)the hypoglycemia-threshold blood glucose level BG_(Hypo) at block 418,the time calculation process 400 determines at block 422 if the mostrecent glucose percent drop BG_(% Drop), is greater than the thresholdglucose percentage drop % Drop_(Low Limit) (for a low BG range) usingthe following equation:BG_(% drop)>% Drop_(Low Limit)  (8A)since

$\begin{matrix}{{BG}_{\%\mspace{11mu}{drop}} = \left( \frac{\left( {{BG}_{P} - {BG}} \right)}{{BG}_{P}} \right)} & \left( {8B} \right)\end{matrix}$then,

$\begin{matrix}{\left( \frac{\left( {{BG}_{P} - {BG}} \right)}{{BG}_{P}} \right) > \;{\%\mspace{20mu}{Drop}_{{Low}\mspace{11mu}{Limit}}}} & \left( {8C} \right)\end{matrix}$where BG_(P) is a previously measured blood glucose.

If the current glucose percent drop BG_(% Drop), is not greater than thelimit for glucose percent drop (for the low BG range) %Drop_(Low Limit), the time calculation process 400 passes the logic toblock 412. In some examples, the low limit % Drop_(Low Limit) equals25%.

Referring back to block 422, if the current glucose percent dropBG_(% Drop) is greater than the limit for glucose percent drop (for thelow BG range) % Drop_(Low Limit), the time calculation process 400 atblock 424 sets the time interval to a shortened time interval T_(Short),for example 20 minutes, to accommodate for the increased drop rate ofthe blood glucose BG. Then the time calculation process 400 is completeand returns to the process 200 (FIG. 2) at block 428.

Referring back to decision block 416, if the time calculation process400 determines that the current blood glucose BG is not below the lowerlimit BG_(TRL) for the blood glucose target range BG_(TR), the timecalculation process 400 determines at block 420 if the blood glucose BGhas decreased by a percent of the previous blood glucose that exceeds alimit % Drop_(Regular) (for the regular range, i.e., blood glucose valueBG>BG_(TRL)), using the formula:

$\begin{matrix}{\left( \frac{\left( {{BG}_{P} - {BG}} \right)}{{BG}_{P}} \right) > {\%\mspace{14mu}{Drop}_{Regular}}} & (9)\end{matrix}$

If the blood glucose BG has decreased by a percentage that exceeds theregular threshold glucose percent drop (for the regular BG range) %Drop_(Regular), the time calculation process 400, at block 425, sets thetime interval to the shortened time interval T_(Short), for example 20minutes. A reasonable value for % Drop_(Regular) for manyimplementations is 66%. Then the time calculation process 400 iscomplete and returns to the process 200 (FIG. 2) at block 428. If,however, the glucose has not decreased by a percent that exceeds thethreshold glucose percent drop % Drop_(Regular), (for the regular BGrange), the time calculation process 400 routes the logic to block 412.The process 400 determines, at block 412, a blood glucose rate ofdescent BG_(DropRate) based on the following equation:BG_(DropRate)=(BG_(P)−BG)/(T _(Current) −T _(Previous))  (10)where BG_(P) is the previous blood glucose measurement, T_(Current) isthe current time and T_(Previous) is the previous time. Moreover, theprocess 400 at block 412 determines if the blood glucose rate of descentBG_(DropRate) is greater than a preconfigured drop rate limitBG_(dropRateLimit).

If the time calculation process 400 at block 412 determines that theblood glucose rate of descent BG_(DropRate), has exceeded thepreconfigured drop rate limit BG_(dropRateLimit), the time intervalT_(Next) until the next blood glucose measurement is shortened at block414 to a glucose drop rate time interval T_(BGDR), which is a relativelyshorter time interval than the current time interval T_(Current), asconsideration for the fast drop. The preconfigured drop rate limitBG_(dropRateLimit) may be about 100 mg/dl/hr. The glucose drop rate timeinterval T_(BGDR) may be 30 minutes, or any other predetermined time. Insome examples, a reasonable value for T_(Default) is one hour. Then thetime calculation process 400 is complete and returns to the process 200(FIG. 2) at block 428.

If the time calculation process 400 determines at block 412 that theglucose drop rate BG_(DropRate) does not exceed the preconfigured limitBG_(dropRateLimit), the time calculation process 400 determines, atblock 408, if the patient's blood glucose concentration BG has beenwithin the desired target range BG_(TR) (e.g., BG_(TRL)<BG<BG_(TRH)) fora period of time T_(Stable). The criterion for stability in the bloodglucose target range BG_(TR) is a specified time in the target rangeBG_(TR) or a specified number of consecutive blood glucose measurementsin the target range BG_(TR). For example, the stable period of timeT_(Stable) may be one hour, two hours, two and a half hours, or up to 4hours. If the stability criterion is met then the time interval T_(Next)until the next scheduled blood glucose measurement BG may be set atblock 410 to a lengthened time interval T_(Long) (such as 2 hours) thatis generally greater than the default time interval T_(Default). Thenthe time calculation process 400 is complete and returns to the process200 (FIG. 2) at block 428. If the time calculation process 400determines that the patient 10 has not met the criteria for stability,the time calculation process 400 sets the time interval T_(Next) to adefault time interval T_(Default) at block 406. Then the timecalculation process 400 is complete and returns to the process 200 (FIG.2) at block 428.

Referring to FIGS. 4B and 4C, once the time calculation process 400calculates the recommended time interval T_(Next), the process 200provides a countdown timer 430 that alerts the user 40 when the nextblood glucose measurement is due. The countdown timer 430 may be on thedisplay 116 of the patient device 110 or displayed on the display 146 ofthe hospital system 140. When the timer 430 is complete, a “BG Due!”message might be displayed as shown in FIG. 4B. The countdown timer 430may include an overdue time 432 indicating the time late if a bloodglucose value is not entered as scheduled.

In some implementations, the countdown timer 430 connects to the alarmsystem 120 of the user device 110. The alarm system 120 may produce anaudible sound via the speaker 122 in the form of a beep or some likeaudio sounding mechanism. The audible and/or visual notification mayalso be sent via the network to the hospital system 140 (or any otherremote station) and displayed on the display 146 of the hospital system140 or played through speakers 152 of the hospital system 140, or routedto the cell phone or pager of the user. In some examples, the audiblealarm using the speakers 122 is turned off by a user selection 434 onthe display 116 or it is silenced for a preconfigured time. The display116, 143 may show information 230 that includes the patient'sintravenous treatment information 230 a or to the patient's subcutaneoustreatment information 230 b. In some examples, the user 40 selects thecountdown timer 430 when the timer 430 indicates that the patient 10 isdue for his or her blood glucose measurement. When the user 40 selectsthe timer 430, the display 116, 146 allows the user 40 to enter thecurrent blood glucose value BG as shown in FIG. 4D. For intravenouspatients 10, the process 200 may ask the user 40 (via the display 116,146) if the blood glucose is pre-meal blood glucose measurement (asshown in FIG. 4D). When the user 40 enters the information 230 (FIG.4D), the user 40 selects a continue button to confirm the enteredinformation 230, which leads to the display 116, 146 displaying bloodglucose information 230 c and a timer 430 showing when the next bloodglucose measurement BG is due (FIG. 4E). In addition, the user 40 mayenter the patient's blood glucose measurement BG at any time before thetimer 430 expires, if the user 40 selects the ‘enter BG’ button 436.Therefore, the user 40 may input blood glucose values BG at any time, orthe user 40 may choose to start the Meal Bolus module process 500 (seeFIG. 5) by selecting the start meal button 438 (FIG. 4E), transition thepatient to SubQ insulin therapy 600 (see FIG. 6), or discontinuetreatment 220.

Referring to FIGS. 5A-5F, in some implementations, the process 200includes a process where the patient's blood glucose level BG ismeasured prior to the consumption of caloric intake and calculates therecommended intravenous mealtime insulin requirement necessary tocontrol the patient's expected rise in blood glucose levels during theprandial period. When a user 40 chooses to start the Meal Bolus process500 (e.g., when the user 40 positively answers that this is a pre-mealblood glucose measurement in FIG. 4D, or when the user 40 selects thestart meal button 438 in FIG. 4E), the Meal Bolus process 500, atdecision block 504, requests the blood glucose BG of the patient 10 (asshown in FIG. 5C). The user 40 enters the blood glucose value BG at 501or the system 100 receives the blood glucose BG from a glucometer 124.This blood glucose measurement is referred to herein as the Pre-Meal BGor BG1. In some examples, where the user 40 enters the information, theuser 40 selects a continue button to confirm the entered information 230c. In some examples, the intravenous meal bolus process 500 isadministered to a patient 10 over a total period of time T_(MealBolus).The total period of time T_(MealBolus) is divided into multiple timeintervals T_(MealBolus1) to T_(MealBolusN), where N is any integergreater than zero. In some examples, a first time intervalT_(MealBolus1) runs from a Pre-Meal blood glucose value BG1 at measuredat time T₁, to a second blood glucose value BG2 at measured at time T₂.A second time interval T_(MealBolus2) runs from the second blood glucosevalue BG2 measured at time T₂ to the third blood glucose value BG3measured at time T₃. A third time interval T_(MealBolus3) runs from thethird blood glucose value BG3 measured at time T₃ to a fourth bloodglucose value BG4 measured at time T₄. In some implementations where thetime intervals T_(MealBolusN) are smaller than T_(Default), the user 40should closely monitor and control over changes in the blood glucose ofthe patient 10. For example, a total period of time T_(MealBolus) equals2 hours, and may be comprised of: T_(MealBolus1)=30 minutes,T_(MealBolus2)=30 minutes, and T_(MealBolus3)=1 hour. This example endson the fourth blood glucose measurement. When the Meal Bolus process 500has been activated, an indication 440 is displayed on the display 116,146 informing the user 40 that the process 500 is in progress. The MealBolus process 500 prompts the user 40 if the entered blood glucose valueBG is the first blood glucose value prior to the meal by displaying aquestion on the patient display 116. If the Meal Bolus process 500determines that the entered blood glucose value BG is the first bloodglucose value (BG1) prior to the meal, then the Meal Bolus process 500freezes the current multiplier M from being adjusted and calculates aregular intravenous insulin rate IRR at block 512. The regularintravenous insulin rate IRR may be determined using EQ. 3A. Meanwhile,at block 502, the Meal Bolus process 500 loads preconfigured mealparameters, such as meal times, insulin type, default number ofcarbohydrates per meal, the total period of time of the meal bolusprocess T_(MealBolus), interval lengths (e.g., T_(MealBolus1),T_(MealBolus1) . . . T_(MealBolusN)), and the percent, “C”, of theestimated meal bolus to be delivered in the first intervalT_(MealBolus1). In some examples, when the system 100 includes ahospital electronic medical record system 140, nutritional informationand number of grams of carbohydrates are retrieved from the hospitalelectronic medical record systems 140 automatically. The Meal Bolusprocess 500 allows the user 40 to select whether to input a number ofcarbohydrates from a selection of standard meals (AcutalCarbs) or to usea custom input to input an estimated number of carbohydrates(EstimatedCarbs) that the patient 10 is likely to consume. The MealBolus process 500 then flows to block 506, where the estimated mealbolus rate for the meal is calculated. The calculation process in block506 is explained in two steps. The first step is calculation of a mealbolus (in units of insulin) in accordance with the following equation:Estimated Meal Bolus=EstimatedCarbs/CIR  (11A)where CIR is the Carbohydrate-to-Insulin Ratio, previously discussed.

The Meal Bolus process 500 then determines the Estimated Meal Bolus Ratebased on the following equation:Estimated Meal Bolus Rate=Estimated Meal Bolus*C/T _(MealBolus1)  (11B)

Where, T_(MealBolus1) is the time duration of the first time interval ofthe Meal Bolus total period of time T_(MealBolus). C is a constantadjusted to infuse the optimum portion of the Estimated Meal Bolusduring first time interval T_(MealBolus1). For instance: if EstimatedMeal Bolus=6 units, T_(MealBolus1)=0.5 hours, and C=25%, then applyingEq. 11A as an example:Estimated Meal Bolus Rate=(6 units)*25%/(0.5 hours)=3 units/hour  (11C)The Meal Bolus process 500 calculates the Total Insulin Rate at block508 as follows:Total Insulin Infusion Rate=Estimated Meal Bolus Rate+RegularIntravenous Rate  (12)

The Meal Bolus process 500 flows to block 510 where it sets the timeinterval for the first interval T_(MealBolus1) to its configured value,(e.g., usually 30 minutes), which will end at the second meal bolusblood glucose (BG2).

After the first time interval T_(MealBolus1) expires (e.g., after 30minutes elapse), the Meal Bolus process 500 prompts the user 40 to enterthe blood glucose value BG once again at block 501. When the Meal Bolusprocess 500 determines that the entered blood glucose value BG is notthe first blood glucose value BG1 entered at block 504 (i.e., thepre-meal BG, BG1, as previously discussed), the process 500 flows toblock 514. At block 514, the Meal Bolus process 500 determines if theblood glucose value BG is the second value BG2 entered by the user 40.If the user 40 confirms that the entered blood glucose value BG is thesecond blood glucose value BG2 entered, the Meal Bolus process 500 usesthe just-entered blood glucose BG2 to calculate the intravenous insulinrate IRR at block 516 and flows to block 524. Simultaneously, if theblood glucose is the second blood glucose BG2, the Meal Bolus process500 prompts the user 40 to enter the actual amount of carbohydrates thatthe patient 10 received at block 518. The Meal Bolus process 500 thendetermines at decision block 520 and based on the inputted amount ofactual carbohydrates, if the patient did not eat, i.e., if the amount ofcarbohydrates is zero (see FIG. 5C). If the Meal Bolus process 500determines that the patient did not eat, the Meal Bolus process 500 thenflows to block 540, where the meal bolus module process 500 isdiscontinued, the multiplier is no longer frozen, and the time intervalT_(Next) is restored to the appropriate time interval T_(Next), asdetermined by process 400. If however, the Meal Bolus process 500determines that the patient 10 ate, i.e., the actual carbohydrates isnot zero (see FIG. 5D), then The Meal Bolus process 500 flows to block522, where it calculates a Revised meal bolus rate according to thefollowing equations, where the Revised Meal Bolus and then an amount ofinsulin (in units of insulin) are calculated:Revised Meal Bolus=ActualCarbs/CIR  (13A)

The process at block 522 then determines the amount (in units ofinsulin) of estimated meal bolus that has been delivered to the patient10 so far:Estimated Meal Bolus Delivered=Estimated Meal Bolus Rate*(T ₂ −T₁)  (13B)where time T1 is the time of when the first blood glucose value BG1 ismeasured and time T2 is the time when the second blood glucose value BG2is measured.

The process at block 522 then calculates the portion of the Revised MealBolus remaining to be delivered (i.e., the Meal Bolus that has not yetbeen delivered to the patient 10) as follows:Revised Meal Bolus Remaining=Revised Meal Bolus−Estimated Meal BolusDelivered  (13C)

The process at block 522 then calculates the Revised Meal Bolus Rate asfollows:Revised Meal Bolus Rate=Revised Meal Bolus Remaining/TimeRemaining  (14A)where Time Remaining=T_(MealBolus)−T_(MealBolus1). Since the total timeinterval T_(MealBolus) and the first time interval T_(MealBolus1) arepreconfigured values, the Time Remaining may be determined.

The Meal Bolus process 500 calculates the total insulin rate at block524 by adding the Revised Meal Bolus Rate to the regular IntravenousRate (IIR), based on the blood glucose value BG:Total Insulin Rate=Revised Meal Bolus Rate+IIR  (14B)

The Meal Bolus process 500 flows to block 526 where it sets the timeinterval T_(Next) to the second interval T_(MealBolus2), which will endat the third meal bolus blood glucose BG3 e.g., usually 30 minutes.

After the second interval, T_(MealBolus2) expires (e.g., 30 minutes),the Meal Bolus process 500 prompts the user 40 to enter the bloodglucose value BG once again at block 501. The Meal Bolus process 500determines that the entered blood glucose value BG is not the firstblood glucose value entered at block 504 (previously discussed) andflows to block 514. The Meal Bolus process 500 determines that theentered blood glucose value BG is not the second blood glucose valueentered at block 514 (previously discussed) and flows to block 528. Atblock 528, the Meal Bolus process 500 determines if the blood glucosevalue BG is the third value entered. If the entered blood glucose valueBG is the third blood glucose value BG entered, the Meal Bolus process500 calculates the intravenous insulin rate IRR at block 530 and flowsto block 532.

At block 532 the process determines the Total Insulin Rate by adding thenewly-determined Regular Intravenous Insulin Rate (IIR) to the RevisedMeal Bolus Rate, which was determined at BG2 and remains effectivethroughout the whole meal bolus time, T_(mealbolus).

The Meal Bolus process 500 flows to block 534 where it sets the timeinterval T_(Next) to the third interval T_(MealBolus3) for the fourthmeal bolus blood glucose, e.g., usually 60 minutes. In someimplementations, more than 3 intervals (T_(MealBolus1), T_(MealBolus2)T_(MealBolus3)) may be used. Additional intervals T_(MealBolusN) mayalso be used and the process handles the additional intervalsT_(MealBolusN) similarly to how it handles the third time intervalT_(MealBolus3). As discussed in the current example, the third intervalT_(MealBolus3) is the last time interval, which ends with themeasurement of the fourth blood glucose measurement BG4.

After the third time interval, T_(MealBolus3), expires (e.g., 60minutes), the Meal Bolus process 500 prompts the user 40 to enter theblood glucose value BG once again at block 501. The Meal Bolus process500 determines that the entered blood glucose value BG is not the firstblood glucose value entered at block 504 (previously discussed) andflows to block 514. The Meal Bolus process 500 determines that theentered blood glucose value BG is not the second blood glucose valueentered at block 514 (previously discussed), nor the third blood glucoselevel entered at block 528 and flows to block 536. At block 536, theMeal Bolus process 500 determines that the inputted blood glucose is thefourth blood glucose value BG4. In this example, the fourth bloodglucose value BG4 is the last one. The process 500 then flows to block538 where the multiplier is no longer frozen, and the time intervalT_(Next) is restored to the appropriate time interval T_(Next), asdetermined by the Timer Adjustment process 400 (FIG. 4A). At this time,the Meal Bolus process 500 ends and the user 40 is prompted with amessage indicating that the Meal Bolus process 500 is no longer active.

As shown in FIG. 5D, and previously discussed with respect to FIGS.4B-4E, the process 200 provides a countdown timer 430 that alerts theuser 40 when the next blood glucose measurement is due. The countdowntimer 430 may be on the display 116 of the patient device 110 ordisplayed on the display 146 of the hospital system 140. When the timer430 is complete, a “BG Due!” message might be displayed as shown in FIG.4B. Moreover, the timer 430 may be a countdown timer or a meal timerindicating a sequence of mealtime intervals (e.g., breakfast, lunch,dinner, bedtime, mid-sleep).

In some implementations, a Meal Bolus process 500 may be implemented bythe following process on a processor 112, 132, 142. Other processes mayalso be used.

 function PreMealIIR($PatientID, $CurrentBG, $Multiplier,$InsulinConcentration,   $EstCarbs, $ActualCarbs, $TimeInterval,$InsulinUnitsOfMeasure, $MealBolusCount) {   $iir = array( );  $CarbInsulinRatio = CIR($PatientID);   $NormalInsulin = ($CurrentBG −60) * $Multiplier;   if($MealBolusCount == 0)   {    //first run −Premeal Bolus    $MealBolus = ($EstCarbs /$CarbInsulinRatio);   if($MealBolus <0)    {$MealBolus = 0;}    $iir[0] = $NormalInsulin +( $MealBolus *.5 );    $iir[2] = ( $MealBolus *.5 );    /*    print“Premeal: MX: ” . $Multiplier . “<BR>”;    print ($CurrentBG − 60) *$Multiplier;    print “ + ” ;    print ( $MealBolus *.5 );    */   }else if($MealBolusCount == 1){    //second run Post Meal Bolus   //third run time interval coming in is actually the    //differencebetween the premeal BG and the first Post Meal BG (second run)   $MealBolus = ($ActualCarbs / $CarbInsulinRatio);    $OldMealBolus =($EstCarbs / $CarbInsulinRatio);    $CurrentMealBolus = ($MealBolus −($OldMealBolus *.5 * $TimeInterval))/1.5;    if($CurrentMealBolus <0)   {$CurrentMealBolus =0;}    $iir[0] = $NormalInsulin +$CurrentMealBolus;    $iir[2] = $CurrentMealBolus ;    /*    print“PlateCheck: <BR>MX: ” . $Multiplier . “<BR>”;    print “Est Carbs: ” .$EstCarbs . “<BR>”;    print “ActualCarbs: ” . $ActualCarbs . “<BR>”;;   print “CarbInsulinRatio: ” . $CarbInsulinRatio . “<BR>”;    print“TimeInterval: ” . $TimeInterval . “<BR>”;    print “Multiplier: ” .$Multiplier;    */   }   else   {    $MealBolus = ($ActualCarbs /$CarbInsulinRatio);    $OldMealBolus = ($EstCarbs / $CarbInsulinRatio);   /*     print “Actual Carbs: ” . $ActualCarbs . “<BR>”;    print “EstCarbs: ” . $EstCarbs . “<BR>”;    print “CIR: ” . $CarbInsulinRatio .“<BR>”;    print “Multiplier: ” . $Multiplier . “<BR>”;    print“CurrentBG: ” . $CurrentBG . “<BR>”;    print “IIR: ” . (($CurrentBG −60) * $Multiplier) . “<BR>”;    print “MealBolus: ” . $MealBolus .“<BR>”;    print “OldMealBolus: ” . $OldMealBolus . “<BR>”;    print“TimeInterval: ” . $TimeInterval . “<BR>”;  */    $CurrentMealBolus =($MealBolus − ($OldMealBolus *.5 * $TimeInterval))/1.5;   if($CurrentMealBolus <0)    {$CurrentMealBolus =0;}    $iir[0] =$NormalInsulin + $CurrentMealBolus;    $iir[2] = $CurrentMealBolus;   /*    print “Post PlateCheck: <BR>MX: ” . $Multiplier . “<BR>”;   print “IIR: ”;    print ($CurrentBG − 60) * $Multiplier . “<BR>”;   print “Est Carbs: ” . $EstCarbs . “<BR>”;    print “Acutal Carbs: ” .$ActualCarbs . “<BR>”;    print “Old Meal bolus: ” . $OldMealBolus .“<BR>”;    print “TimeInterval: ” . $TimeInterval . “<BR>”;    print“Meal bolus: ” . $MealBolus . “<BR>”;    print “Final Calc: ” . $iir[0];   */   }   if ($InsulinUnitsOfMeasure != “units/hr”)   {    $iir[0] =$iir[0]/$InsulinConcentration;   }   return $iir; }

Referring to FIGS. 2A and 6A, if the user elects to initiate the SubQTransition process 600, the SubQ Transition process 600 determines atdecision block 604 if the current blood glucose BG is within apreconfigured stability target range BG_(STR), e.g., 70-180 mg/dl, whichis usually wider than the prescribed Target Range, BG_(TR). If the bloodglucose BG is not within the preconfigured stability target rangeBG_(STR) (e.g., BG_(Low)<BG<BG_(High)), the SubQ Transition process 600at block 606 displays a warning notification on the patient display 116.Then, at lock 610, the SubQ Transition process 600 is automaticallydiscontinued.

Referring back to block 604, if the blood glucose BG is within thepreconfigured stability target range BG_(STR) (e.g. 70-180 mg/dl), theSubQ Transition process 600 at decision block 608 determines if thepatient's blood glucose measurement BG has been in the patient'spersonalized prescribed target range BG_(TR) for the recommendedstability period T_(Stable), e.g., 4 hours. If the SubQ Transitionprocess 600 determines that the blood glucose value BG has not been inthe prescribed target range BG_(STR) for the recommended stabilityperiod T_(Stable), the SubQ Transition process 600 moves to block 614where the system 100 presents the user 40 with a warning notification onthe patient display 116, explaining that the patient 10 has not been inthe prescribed target range for the recommended stability period (seeFIG. 6C). The SubQ Transition process 600 continues to decision block618 where it determines whether the user 40 wants the patient 10 tocontinue the SubQ Transition process or to discontinue the SubQTransition process. The SubQ Transition process 600 displays on thedisplay 116 of the patient device 110 the question to the user 40 asshown in FIG. 6D. If the user 40 chooses to discontinue the SubQTransition process, the SubQ Transition process 600 flows to block 624,where the SubQ Transition process is discontinued.

Referring back to block 618, if the user 40 chooses to override thewarning and continue the SubQ Transition process, the process 600prompts the user 40 to enter SubQ information 617. The SubQ Transitionprocess 600 flows to block 616, where the patient's SubQ Transition doseis calculated as a patient's total daily dose TDD. In someimplementations, TDD is calculated in accordance with equation:TDD=QuickTransitionConstant*M _(Trans)  (15A)where QuickTransitionConstant is usually 1000, and M_(Trans) is thepatient's multiplier at the time of initiation of the SubQ transitionprocess.

Referring again to block 616, in some implementations TDD is calculatedby a statistical correlation of TDD as a function of body weight. Thefollowing equation is the correlation used:TDD=0.5*Weight (kg)  (15B)

The SubQ Transition process 600 continues to block 620, where therecommended SubQ dose is presented to the user 40 (on the display 116)in the form of a Basal recommendation and a Meal Bolus recommendation(see FIG. 6F).

Referring again to decision block 608, if the SubQ Transition process600 determines that the patient 10 has been in the prescribed targetrange BG_(TR) for the recommended stability period, T_(Stable), SubQTransition process 600 continues to block 612, where the patient's totaldaily dose TDD is calculated in accordance with the following equation:TDD=(BG_(Target) −K)*(M _(Trans))*24  (16)where M_(Trans) is the patient's multiplier at the time of initiation ofthe SubQ transition process.

In some implementations, the patient's total daily dose TDD may bedetermined by the following process on a processor 112, 132, 142. Otherprocesses may also be used.

function getIV_TDD($PatientID)

{

//weight=getOneField(“weight”, “patients”, “patientID”, $PatientID);

//return $weight/2;

$CI=get_instance( );

$CI→load→model(‘options’);

$d=$CI→options→GetIVTDDData($PatientID);

$TargetHigh=$d[“TargetHigh”];

$TargetLow=$d[“TargetLow”];

$Multiplier=$d[“Multiplier”];

$MidPoint=($TargetHigh+$TargetLow)/2;

$Formula=($MidPoint−60)*$Multiplier*24;

return $Formula;

}

When the patient's total daily dose TDD is calculated, the SubQTransition process 600 continues to block 620 where the recommended SubQdose is presented to the user 40 as described above. The SubQ Transitionprocess 600 continues to block 622, where the SubQ Transition process600 provides information to the user 40 including a recommended dose ofBasal insulin. The user 40 confirms that the Basal insulin has beengiven to the patient 10; this starts a transitions timer using theTransitionRunTime_(Next), usually 4 hours. At this point, normalcalculation rules governing the IIR are still in effect, including theintravenous IIR timer (Timer Adjustment process 400), which continues toprompt for blood glucose tests at time intervals T_(Next) as describedpreviously. The SubQ Transition process 600 passes to decision block626, which determines whether the recommended time intervalTransitionRunTime has elapsed, e.g., 4 hours, after which time SubQTransition process 600 continues to block 630, providing the user withsubcutaneous insulin discharge orders and exiting the IV Insulin processin block 634.

FIG. 7 provides an arrangement of operations for a method 700 ofadministering intravenous insulin to a patient 10. The method 700includes receiving 702 blood glucose measurements BG on a computingdevice (e.g., a processor 112 of a patient device 110, a processor 152of a hospital electronic medical record system 150, or a data processor132 of a service provider 130) of a dosing controller 160 from a bloodglucose measurement device 124 (e.g., glucose meter or glucometer). Theblood glucose measurements BG are separated by a time interval T_(Next).The method 700 includes determining 704, using the computing device 112,132, 152, an insulin dose rate IIR based on the blood glucosemeasurements BG. In some implementations, the method 700 determines theinsulin dose rate IRR based on a current blood glucose measurement BG, aconstant K, and a multiplier M (see EQ. 3A above). The constant K mayequal 60 mg/dl. The method 700 includes leaving the multiplier Munchanged between time intervals T_(Next) when the current blood glucosemeasurement BG is greater than an upper limit BG_(TRH) of the bloodglucose target range BG_(TR) and the blood glucose percent dropBG_(% Drop) from the previous blood glucose value BG_(P) is greater thanor equal to a desired percent drop BG % drop M (see EQ. 5). The method700 also includes multiplying the multiplier M by a change factor M_(CF)when the current blood glucose measurement BG is greater than an upperlimit BG_(TRH) of the blood glucose target range BG_(TR) and the bloodglucose percent drop BG_(% Drop) (or blood glucose percent drop) is lessthan the desired percent drop BG % drop M. Additionally oralternatively, the method 700 includes leaving the multiplier Munchanged between time intervals T_(Next) when the current blood glucosemeasurement BG is in the target range BG_(TR) i.e. when BG is less thanan upper limit BG_(TRH) of the blood glucose target range and greaterthan the lower limit BG_(TRL) of the target range, BG_(TR). The method700 also includes dividing the multiplier M by a change factor M_(CF)when the current blood glucose measurement BG is less than the lowerlimit BG_(TRL) of the blood glucose target range BG_(TR). The method 700may include setting the time interval T_(Next) to a hypoglycemia timeinterval T_(Hypo) of between about 15 minutes and about 30 minutes, whenthe current blood glucose measurement BG is below a hypo-threshold bloodglucose level BG_(Hypo).

The method 700 includes determining 706 a blood glucose drop rateBG_(DropRate) based on the blood glucose measurements BG and the timeinterval T_(Next). The method 700 includes determining 707 a bloodglucose percent drop BG_(% Drop), using the computing device 112, 132,152 from a previous blood glucose measurement BG_(P). When the bloodglucose drop rate BG_(DropRate) is greater than a threshold drop rateBG_(DropRateLimit), the method 700 includes decreasing at 708 the timeinterval T_(Next) between blood glucose measurements measure by theglucometer.

The method 700 also includes decreasing 710 the time interval T_(Next)between blood glucose measurements BG when the percent drop BG_(% Drop)of the blood glucose BG is greater than the threshold of the percentdrop % Drop_(Regular), where the threshold of the percent drop %Drop_(Regular) depends on whether the current blood glucose measurementBG is below a lower limit BG_(TRL) of a blood glucose target rangeBG_(TR). In some implementations, the method 700 includes decreasing thetime interval T_(Next) when the current blood glucose measurement BG isgreater than or equal to the lower limit BG_(TRL) of the blood glucosetarget range BG_(TR) and the blood glucose percent drop BG_(% Drop)exceeds a threshold percent drop % Drop_(Regular). In someimplementations, the method 700 includes decreasing the time intervalT_(Next) when the current blood glucose measurement BG is below thelower limit BG_(TRL) of the blood glucose target range BG_(TR) and abovethe hypo-threshold blood glucose level BG_(Hypo), and the blood glucosepercent drop BG_(% Drop) is greater than or equal to a threshold percentdrop % Drop_(LowLimit).

In some examples, the method 700 includes leaving the multiplier Munchanged for at least two subsequent time intervals, T_(Next), when thecurrent blood glucose measurement BG is a pre-meal measurement. In someexamples, the method 700 includes receiving, on the computing device112, 132, 142, a number of carbohydrates for a meal as well as a bloodglucose measurement, and determining, using the computing device 112,132, 142, an intravenous insulin rate IIR based on the blood glucose(this IIR may be calculated using EQ. 3A). In addition, the method 700includes determining, using the computing device 112, 132, 142, a mealbolus insulin rate IIR based on the number of carbohydrates. The method700 then calculates a Total insulin rate as the sum of the meal bolusrate and the regular intravenous rate as shown in EQ. 12. The method 700may further include setting the time interval T_(Next) to about 30minutes. If the blood glucose measurement BG is a second consecutivemeasurement after (but not including) an initial pre-meal blood glucosemeasurement BG, the method 700 includes setting the time intervalT_(Next) to about 30 minutes.

In some implementations, the method 700 includes electronicallydisplaying on a display 116, 146 a warning and blocking transition to asubcutaneous administration of insulin when the current blood glucosemeasurement BG is outside a stability target range BG_(STR). Inaddition, the method 700 includes electronically displaying on thedisplay 116, 146 a warning when the current blood glucose measurement BGis within the patient's personalized target range BG_(TR) for less thana threshold stability period of time T_(Stable). In some examples, themethod 700 includes determining a total daily dose of insulin TDD basedon the multiplier M when the current blood glucose measurement BG iswithin a stability target range BG_(STR) for a threshold stabilityperiod of time T_(Stable).

Various implementations of the systems and techniques described here canbe realized in digital electronic circuitry, integrated circuitry,specially designed ASICs (application specific integrated circuits),computer hardware, firmware, software, and/or combinations thereof.These various implementations can include implementation in one or morecomputer programs that are executable and/or interpretable on aprogrammable system including at least one programmable processor, whichmay be special or general purpose, coupled to receive data andinstructions from, and to transmit data and instructions to, a storagesystem, at least one input device, and at least one output device.

These computer programs (also known as programs, software, softwareapplications or code) include machine instructions for a programmableprocessor and can be implemented in a high-level procedural and/orobject-oriented programming language, and/or in assembly/machinelanguage. As used herein, the terms “machine-readable medium” and“computer-readable medium” refer to any computer program product,apparatus and/or device (e.g., magnetic discs, optical disks, memory,Programmable Logic Devices (PLDs)) used to provide machine instructionsand/or data to a programmable processor, including a machine-readablemedium that receives machine instructions as a machine-readable signal.The term “machine-readable signal” refers to any signal used to providemachine instructions and/or data to a programmable processor.

Implementations of the subject matter and the functional operationsdescribed in this specification can be implemented in digital electroniccircuitry, or in computer software, firmware, or hardware, including thestructures disclosed in this specification and their structuralequivalents, or in combinations of one or more of them. Moreover,subject matter described in this specification can be implemented as oneor more computer program products, i.e., one or more modules of computerprogram instructions encoded on a computer readable medium for executionby, or to control the operation of, data processing apparatus. Thecomputer readable medium can be a machine-readable storage device, amachine-readable storage substrate, a memory device, a composition ofmatter affecting a machine-readable propagated signal, or a combinationof one or more of them. The terms “data processing apparatus”,“computing device” and “computing processor” encompass all apparatus,devices, and machines for processing data, including by way of example aprogrammable processor, a computer, or multiple processors or computers.The apparatus can include, in addition to hardware, code that creates anexecution environment for the computer program in question, e.g., codethat constitutes processor firmware, a protocol stack, a databasemanagement system, an operating system, or a combination of one or moreof them. A propagated signal is an artificially generated signal, e.g.,a machine-generated electrical, optical, or electromagnetic signal thatis generated to encode information for transmission to suitable receiverapparatus.

A computer program (also known as an application, program, software,software application, script, or code) can be written in any form ofprogramming language, including compiled or interpreted languages, andit can be deployed in any form, including as a stand-alone program or asa module, component, subroutine, or other unit suitable for use in acomputing environment. A computer program does not necessarilycorrespond to a file in a file system. A program can be stored in aportion of a file that holds other programs or data (e.g., one or morescripts stored in a markup language document), in a single filededicated to the program in question, or in multiple coordinated files(e.g., files that store one or more modules, sub programs, or portionsof code). A computer program can be deployed to be executed on onecomputer or on multiple computers that are located at one site ordistributed across multiple sites and interconnected by a communicationnetwork.

The processes and logic flows described in this specification can beperformed by one or more programmable processors executing one or morecomputer programs to perform functions by operating on input data andgenerating output. The processes and logic flows can also be performedby, and apparatus can also be implemented as, special purpose logiccircuitry, e.g., an FPGA (field programmable gate array) or an ASIC(application specific integrated circuit).

Processors suitable for the execution of a computer program include, byway of example, both general and special purpose microprocessors, andany one or more processors of any kind of digital computer. Generally, aprocessor will receive instructions and data from a read only memory ora random access memory or both. The essential elements of a computer area processor for performing instructions and one or more memory devicesfor storing instructions and data. Generally, a computer will alsoinclude, or be operatively coupled to receive data from or transfer datato, or both, one or more mass storage devices for storing data, e.g.,magnetic, magneto optical disks, or optical disks. However, a computerneed not have such devices. Moreover, a computer can be embedded inanother device, e.g., a mobile telephone, a personal digital assistant(PDA), a mobile audio player, a Global Positioning System (GPS)receiver, to name just a few. Computer readable media suitable forstoring computer program instructions and data include all forms ofnon-volatile memory, media and memory devices, including by way ofexample semiconductor memory devices, e.g., EPROM, EEPROM, and flashmemory devices; magnetic disks, e.g., internal hard disks or removabledisks; magneto optical disks; and CD ROM and DVD-ROM disks. Theprocessor and the memory can be supplemented by, or incorporated in,special purpose logic circuitry.

To provide for interaction with a user, one or more aspects of thedisclosure can be implemented on a computer having a display device,e.g., a CRT (cathode ray tube), LCD (liquid crystal display) monitor, ortouch screen for displaying information to the user and optionally akeyboard and a pointing device, e.g., a mouse or a trackball, by whichthe user can provide input to the computer. Other kinds of devices canbe used to provide interaction with a user as well; for example,feedback provided to the user can be any form of sensory feedback, e.g.,visual feedback, auditory feedback, or tactile feedback; and input fromthe user can be received in any form, including acoustic, speech, ortactile input. In addition, a computer can interact with a user bysending documents to and receiving documents from a device that is usedby the user; for example, by sending web pages to a web browser on auser's client device in response to requests received from the webbrowser.

One or more aspects of the disclosure can be implemented in a computingsystem that includes a backend component, e.g., as a data server, orthat includes a middleware component, e.g., an application server, orthat includes a frontend component, e.g., a client computer having agraphical user interface or a Web browser through which a user caninteract with an implementation of the subject matter described in thisspecification, or any combination of one or more such backend,middleware, or frontend components. The components of the system can beinterconnected by any form or medium of digital data communication,e.g., a communication network. Examples of communication networksinclude a local area network (“LAN”) and a wide area network (“WAN”), aninter-network (e.g., the Internet), and peer-to-peer networks (e.g., adhoc peer-to-peer networks).

The computing system can include clients and servers. A client andserver are generally remote from each other and typically interactthrough a communication network. The relationship of client and serverarises by virtue of computer programs running on the respectivecomputers and having a client-server relationship to each other. In someimplementations, a server transmits data (e.g., an HTML page) to aclient device (e.g., for purposes of displaying data to and receivinguser input from a user interacting with the client device). Datagenerated at the client device (e.g., a result of the user interaction)can be received from the client device at the server.

While this specification contains many specifics, these should not beconstrued as limitations on the scope of the disclosure or of what maybe claimed, but rather as descriptions of features specific toparticular implementations of the disclosure. Certain features that aredescribed in this specification in the context of separateimplementations can also be implemented in combination in a singleimplementation. Conversely, various features that are described in thecontext of a single implementation can also be implemented in multipleimplementations separately or in any suitable sub-combination. Moreover,although features may be described above as acting in certaincombinations and even initially claimed as such, one or more featuresfrom a claimed combination can in some cases be excised from thecombination, and the claimed combination may be directed to asub-combination or variation of a sub-combination.

Similarly, while operations are depicted in the drawings in a particularorder, this should not be understood as requiring that such operationsbe performed in the particular order shown or in sequential order, orthat all illustrated operations be performed, to achieve desirableresults. In certain circumstances, multi-tasking and parallel processingmay be advantageous. Moreover, the separation of various systemcomponents in the embodiments described above should not be understoodas requiring such separation in all embodiments, and it should beunderstood that the described program components and systems cangenerally be integrated together in a single software product orpackaged into multiple software products.

A number of implementations have been described. Nevertheless, it willbe understood that various modifications may be made without departingfrom the spirit and scope of the disclosure. Accordingly, otherimplementations are within the scope of the following claims. Forexample, the actions recited in the claims can be performed in adifferent order and still achieve desirable results.

What is claimed is:
 1. A system comprising: a glucometer measuring bloodglucose measurements separated by a time interval; an insulinadministration device; and a dosing controller in communication with theglucometer and the insulin administration device, the dosing controllerincluding data processing hardware and non-transitory memory incommunication with the data processing hardware, the non-transitorymemory storing instructions that when executed by the data processinghardware cause the data processing hardware to perform operationscomprising: receiving blood glucose measurements for a patient from theglucometer, the blood glucose measurements comprising a current bloodglucose measurement measured at a current time and a previous bloodglucose measurement measured at a previous time earlier than the currenttime, wherein an elapsed time between the current time and the previoustime defines a current time interval; determining an intravenous insulininfusion rate based on the current blood glucose measurement and theprevious blood glucose measurement; determining a blood glucosepercentage drop based on the current blood glucose measurement and theprevious blood glucose measurement; determining a blood glucose droprate based on the current blood glucose measurement, the previous bloodglucose measurement, and the current time interval; determining a nexttime interval from the current time until a next time of a nextscheduled blood glucose measurement for the patient based on the currentblood glucose measurement, the next time interval comprising a shorterduration of time than the current time interval when: the blood glucosepercentage drop is greater than a threshold percentage drop; or theblood glucose drop rate is greater than a threshold drop rate; andsending the intravenous insulin infusion rate from the data processinghardware to the insulin administration device in communication with thedata processing hardware, and when the insulin administration devicereceives the intravenous insulin infusion rate, the insulinadministration device configured to administer insulin to the patientintravenously using the intravenous insulin infusion rate.
 2. The systemof claim 1, wherein the operations further comprise: obtaining patientinformation from the non-transitory memory, the patient informationcomprising: a target blood glucose range for the patient comprising arange of blood glucose values between and including a lower limit bloodglucose value and an upper limit blood glucose value greater than thelower limit blood glucose value; a threshold hypoglycemia blood glucosevalue for the patient, the threshold hypoglycemia blood glucose valueless than the lower limit blood glucose value of the target bloodglucose range; a low blood glucose percentage drop limit for the patientwhen the current blood glucose measurement is less than the lower limitblood glucose value of the target blood glucose range; a regular bloodglucose percentage drop limit for the patient when the current bloodglucose measurement is greater than or equal to the lower limit bloodglucose value of the target blood glucose range; a blood glucose droprate limit for the patient; and a stable time period comprising arecommended duration of time required for the current blood glucosemeasurement within the target blood glucose range to determine a bloodglucose concentration for the patient is stable in the target bloodglucose range, wherein determining the next time interval comprisessetting the next time interval to a default time interval or one: apreconfigured hypoglycemia time interval when the current blood glucosemeasurement is less than the threshold hypoglycemia blood glucose value;a preconfigured short time interval when: the current blood glucosemeasurement is greater than the threshold hypoglycemia blood glucosevalue and less than the lower limit blood glucose value of the targetblood glucose range and the blood glucose percentage drop is greaterthan the low blood glucose percentage drop limit; or the current bloodglucose measurement is greater than or equal to the lower limit bloodglucose value of the target blood glucose range and the blood glucosepercentage drop is greater than the regular blood glucose percentagedrop limit; a preconfigured blood glucose drop rate time interval whenthe blood glucose drop rate is greater than the blood glucose drop ratelimit; a preconfigured long time interval when the current blood glucosemeasurement has been within the blood glucose target range for aduration of time greater than the stable time period; or a preconfiguredmeal bolus time interval when a meal bolus program is in operation, andwherein the hypoglycemia time interval is less than the short timeinterval, the short time interval is less than the blood glucose droprate time interval, the blood glucose drop rate time interval is lessthan the long time interval, and the meal bolus time interval is lessthan the long time interval.
 3. The system of claim 2, whereindetermining the intravenous insulin infusion rate comprises calculating:IIR=(BG−K)*M wherein IIR is the intravenous insulin infusion rate, BG isthe current blood glucose measurement, K is a constant, and M is amultiplier, wherein determining the blood glucose percentage dropcomprises calculating:${{Percentage}\mspace{14mu}{drop}} = \left( \frac{\left( {{BG}_{Previous} - {BG}} \right)}{{BG}_{Previous}} \right)$wherein BG_(Previous) is the previous blood glucose measurement and BGis the current blood glucose measurement, and wherein determining theblood glucose drop rate comprises calculating:BG_(DropRate)(BG_(Previous)−BG)/(T _(Current) −T _(Previous)) whereinBG_(DropRate) is the blood glucose drop rate, BG is the current bloodglucose measurement, BG_(Previous) is the previous blood glucosemeasurement, T_(Current) is the current time and T_(Previous) is theprevious time.
 4. The system of claim 3, wherein the operations furthercomprise: leaving the multiplier unchanged between time intervals whenthe current blood glucose measurement is greater than the upper limitblood glucose value of the target blood glucose range and a ratio of thecurrent blood glucose measurement divided by the previous blood glucosemeasurement is less than or equal to a threshold ratio; and multiplyingthe multiplier by a change factor when the current blood glucosemeasurement is greater than the upper limit blood glucose value of thetarget blood glucose range and the ratio of the current blood glucosemeasurement divided by the previous blood glucose measurement is greaterthan the threshold ratio.
 5. The system of claim 4, wherein the constantK equals 60 mg/dl and the threshold ratio is 0.85.
 6. The system ofclaim 4, wherein the operations further comprise dividing the multiplierby the change factor when the current blood glucose measurement is lessthan the lower limit blood glucose value of the target blood glucoserange.
 7. The system of claim 3, wherein, in response to receiving anindication of patient solid food consumption, the operations furthercomprise increasing the intravenous insulin infusion rate andmaintaining the multiplier unchanged for at least two time intervals. 8.The system of claim 7, wherein the operations further comprise:receiving a number of estimated grams of carbohydrates for a meal;determining an estimated meal bolus in units of insulin based on thenumber of estimated grams of carbohydrates and acarbohydrate-insulin-ratio; determining an estimated meal bolus insulinrate, based on the estimated meal bolus, an available delivery time, anda configurable constant; determining a total insulin rate as a sum ofthe intravenous insulin rate and the estimated meal bolus insulin rate;and sending the total insulin rate from the data processing hardware tothe insulin administration device.
 9. The system of claim 8, wherein theoperations further comprise: dividing a total meal time into meal timesub-intervals, a first meal time sub-interval starting with a pre-mealblood glucose measurement before receiving the indication of patientsolid food consumption; and determining the total insulin rate for eachmeal time sub-interval in succession.
 10. The system of claim 9, whereinthe operations further comprise: receiving a number of actual grams ofcarbohydrates for the meal during a subsequent meal time sub-intervalafter the first meal time sub-interval; determining an actual meal bolusbased on the number of actual grams of carbohydrates; determining anestimated delivered meal bolus by multiplying the estimated meal bolusrate by an elapsed delivery time; determining a remaining meal bolus inunits of insulin by subtracting a product of the estimated deliveredmeal bolus insulin rate and an actual delivery time from the actual mealbolus; determining a revised meal bolus insulin rate as the remainingmeal bolus divided by a time remaining in the total meal time;determining a revised total insulin rate as a sum of the intravenousinsulin rate and the revised meal bolus insulin rate; and sending therevised total insulin rate from the data processing hardware to theinsulin administration device.
 11. The system of claim 10, wherein oneor more of the meal time sub-intervals comprise a shorter duration oftime than the default time interval.
 12. The system of claim 11, whereinthe operations further comprise: electronically displaying on a displayin communication with the data processing hardware a warning andblocking transition to a subcutaneous administration of insulin when thecurrent blood glucose measurement is outside a stability target rangeincluded within the obtained patient information, the stability targetrange comprising a wider range of blood glucose values than the range ofblood glucose values associated with the target blood glucose range; andelectronically displaying on the display a warning when the currentblood glucose measurement is within the stability target range for lessthan a threshold stability period of time.
 13. The system of claim 3,wherein the operations further comprise: determining a total daily doseof insulin based on the multiplier when the current blood glucosemeasurement is within a stability target range for a threshold stabilityperiod of time; determining recommended insulin doses comprising a dailybasal insulin and a daily meal insulin for subcutaneous therapy as anapportioning of the total daily dose of insulin, wherein the daily basalinsulin is half of the total daily dose of insulin and the daily mealinsulin is half of the total daily dose of insulin; and sending therecommended insulin doses from the data processing hardware to asubcutaneous injection device or electronically displaying therecommended insulin doses on a display in communication with the dataprocessing hardware.
 14. The system of claim 13, further comprisingdetermining the total daily dose of insulin by calculating:TDD=(BG_(Target) −K)*(M _(Trans))*24 wherein TDD is the total daily doseof insulin, M_(Trans) is a current multiplier at a moment of initiationof a process of a transition to subcutaneous insulin treatment; andBG_(Target) is determined by calculating:BG_(Target)=(BR_(TRH)+BR_(TRL))/2 wherein BR_(TRH) is the upper limitblood glucose value of the blood glucose target range and BR_(TRL) isthe lower limit blood glucose value of the target blood glucose range.15. The system of claim 13, further comprising determining the totaldaily dose of insulin as a function of a patient body weight bycalculating:TDD=0.5*Weight wherein TDD is the total daily dose of insulin and Weightis a patient body weight in kilograms.